www.shtopview.com
Fiscal Year 2019
CERTIFICATION OF REGISTRATION
This certifies that:
Shanghai Top View Industrial Co., Ltd
No.3388 GongHeXin Road,JingAn,shanghai,CHINA
has completed the FDA Establishment Registration (as manufacturer , foreign exporter,
contract manufacturer ) and Device Listing with the US Food & Drug Administration,
through
U.S. Agent for FDA
Communications:
SUNGO TECHNICAL SERVICE INC.
6050 W EASTWOOD AVE APT 201, CHICAGO,
ILLINOIS 60630, USA
Telephone: +1-855-957-7779 / E-mail: sungo.group@yahoo.com
Owner/Operator Number: 10059986
Device Listing#: See annex
SUNGO Technical Service Inc. will confirm that such registration remains effective upon request and
presentation of this certificate until the end of the calendar year stated above, unless said registration is
terminated after issuance of this certificate. SUNGO Technical Service Inc. makes no other
representations or warranties, nor does this certificate make any representations or warranties to any
person or entity other than the named certificate holder, for whose sole benefit it is issued. This
certificate does not denote endorsement or approval of the certificate-holder’s device or establishment
by the U.S. Food and Drug Administration. SUNGO Technical Service Inc. assumes no liability to any
person or entity in connection with the foregoing.
Pursuant to 21 CFR 807.39, “Registration of a device establishment or assignment of a registration
number does not in any way denote approval of the establishment or its products. Any representation
that creates an impression of official approval because of registration or possession of a registration
number is misleading and constitutes misbranding.” The U.S. Food and Drug Administration does not
issue a certificate of registration, nor does the U.S. Food and Drug Administration recognize a
certificate of registration, SUNGO Technical Service Inc. is not affiliated with the U.S. Food and Drug
Administration.
Executive Director
Issued: Mar. 18 2019
Cert. No.: 2006US842518
Expiration Date: Dec. 31 2019
Fiscal Year 2019
CERTIFICATION OF REGISTRATION
Annex to Cert. No.: 2006US842518
Listing No
Code
D345115
HKO
D345116
HKN
D345117
HKZ
D345118
PJZ
D345119
PUE
D345120
HRJ
D345121
HLM
D345122
HPA
D345123
HPC
D345124
HOX
D345125
HPT
Device Name
Refractometer, ophthalmic
(TPV800 handheld refractor; TPV series auto refractometer)
Refractor, manual, non-powered, including phoropter
(phoropter)
Sterilizer, tonometer
(TPV500 TONOMETER)
Camera, ophthalmic, general-use
(Hand-held Fundus Camera; TPV series Digital Fundus Camera)
Biomicroscope, slit-lamp, AC-powered, exempt
(TPV series slit lamp)
Table, instrument, powered, ophthalmic
(Ophthalmic unit)
Instrument, measuring, lens, ac-powered
(TPV series lens meter)
Frame, trial, ophthalmic
(trial frame)
Set, lens, trial, ophthalmic
(trial lens set)
Chart, visual acuity
(visual charter)
Perimeter, automatic, ac-powered
(PERIMETER)
END OF THE ANNEX
「 Techni叫arameters
I
New optical system, unique 1mag1ng 1mpress1on
H口「lman im 口ging 口 n口lyzing 口nd processing technology, occur口te me口sure 『nent result
TFT touch screen, can move front and back什eely
Mo↑orized chinrest
Auto paper-cu忖1ng printer
Auto tracking and focusing during measuring
Vertex Distance(VD): 0.0, 12.0, 13.75, 15.0
SPH: -30.00D～＋25.00D (VD=12mm, 0.01, 0.06, 0.12, 0.25 Unit)
CYL: O.OOD－士10.00D (0 06, 0.12, 0.25 U 「l it)
Axis(AX): 1°
～ 180 。
Cylinder Form ：
一
， ＋，
C1 。 U 「1it)
士
Puiple Distance(PD): 10～86mm
Minimum Pupil Diameter: 2.0mm
Measuring Time: < 0.5s
Pupil Diameter: 2.00-8.00mm
Measuring Light Energy: < 30uw C lnsu 「e measuring safety)
国l圃
二－：
’..锺＆·锺P如·“ 审，即也....，，..‘一
f'�
L一一J
Radius of Curvature: 5.0～10.0mm (0.01mm Unit)
Corneal Power: 33.00D～67.00D
CI n case that the co 「neal equivale 「lt 「efractive powe 「 is 1.3375)
Corneal Astigmatism: O.OOD～ －15.00D〔0060/0 120/0 25D Unit)
Data Storing: Each 10 measu 「ed values of left eyes and 「ight eyes
Axis: 1 ° ～180。
Cha「t: Auto fog
Monitor: SHARP 7 ” TFT LCD touch sc 「een (Angle of view adjustable)
-,'
L
飞
��力
Built-in Printer: 57mm the 「mal p 「inte 「， auto pape 「 －cutting
Electrical Power: AC 100～250V, 50/60Hz
N.W.: 22kg
G.W.: 26.5kg
Dimensions(packing): (L)680mm×（W)400mm×（H)640mm
。
www.sht pview.贷m
「 Techni叫arameters
I
ARK-1610
Main Features
-New optical system, unique imaging impression.
-Hartman imaging analyzing and processing
technology, accurate measurement result.
-TFT touch screen, can move front and back freely
-Motorized chinrest
-Auto paper-cutting printer
SPH: -30.00D ～＋25.00D(VD=12mm, 0.01, 0.06, 0.12, 0.25 Unit)
CYL: O.OOD ～士10.00D(0.06, 0.12, 0.25 Unit)
Axis(AX): 1。 ～180。｛俨Un忧｝
Cylinder Form: －，飞主
Pupil Distance(PD): 10-86mm
Minimum Pupil Distance: 2.0mm
Measuring Time ： ζ0.5s
Pupil Diamete 『： 2.00-8.00mm
Measuring Light Energy: L30uw(lnsure measl』ring safety)
Radius of Curvatt.』re: 5.0-10.0mm(0.01mm Unit)
Corneal Power: 33.00D-67.OOD(ln 臼se that the corneal equivalent 『e行active power is 1.3375)
Corneal Astigmatism: O.OOD～－15.00D(0.06D/0.12D/0.25D Unit)
Data Storing: Each 10 measu 『ed values of left eyes and right eyes
Axis: 1。 ～180°
Cha此：Auto fog
”
Monitor: SHARP 7 TFT LCD touch sc 陀 en(Angle of view adjustable)
Built-in Printe 『： 57mm thermal printe几auto pape 仁cutting
Electric Power: AC 100～250V, 50/60Hz
N.W.: 22kgs
G.W.: 26.5kgs
Dimensions(packing): (L)680mmX(W)400mmX(H)640mm
。
www.sht pview嗖m
「 Techni叫arameters
I
/IR-83011 IIIRK-830
Auto Ref /Keratometer
Specifications
E医�
阳1刷刷’’I司用
rrt:I百阳市雪白宫
由fo斗目
KER /REF (ARK-830)
REF
KER (ARK-830)
SIZE (ARK-830)
Venex Distance (VD)
Sphere (S)
Cylinder (C)
Axis (A)
Cylinder Form
Pupil Distance (PD)
Minimum Pupil Diameter
Measuring time
Radius of Curvature (ARK-830)
Corneal Refractomelry (ARK-830)
Corneal Astgmatism (ARK-830)
Corneal Diameter (ARK-830)
Printer
Power Save
Display
Auto Tracing Function Range
Power
Dimensions I weight
Jaw Panel
Keratometer I Retractometer
Retractomete 「
Keratometer
Corned radius
0, 12, 13.75, 15mm
-20.00 - +20.00D (VD=12mm, 0.12 o 「 0.25D Steps)
0.00 ～＋／－10.00D (0.12 or 0.25D Steps)
1-180。 （Steps 1 。 ）
－、 ＋、 ＋／－
30～85 mm
φ2.2mm
0.5sec
5.0-10mm
33.00～ 67.00D
0.00 ～－15.00D (0.12/0.25D Steps)
2.0 ～ 12.0mm
Thermal Printer
5, 15 Min
7” TFT LCD (touch screen)
±16mm (up and down direction only)
AC100 ～ 240V, 50/60Hz/90W
480(L) x 270(W) x 445(H)mm/17kg
Max 55mm
*Specifications above are subject to change without notice.
。
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MORE PRODUCT
1
S_eecification:
旦旦伊且直
翩 翩
m
z
且回o rel/keratometer
m&I
Cornea / refractometry measurement mode
阳悟asurement mode M de of keratometrv
Refractometry measurement mode
VertexDistance
Spherical deqree
Cylinder degree
Axial
Re 『actometry
Cylinder Symbol
pupil distance
Minimum pupil diameter
阳teasuring time
Radius ofcurvature
Corneal refractometry
[Keratomet叩
Corneal asti日matism
Co「neal diameter
printer
Saving Settings
M nitors
Others
Auto Tracina Function Ranae
Po辆ier
Size I Weiqht
Jaw panel
。
。
keratometry/refractometry
re 『act metrv
keratometry
0,10 ,12,13.5 ,15mm
-20.00叶20.00D ( VD=12mm ,o.12or 0.25D )
0.00叶ι8.000(0.12or 0.250)
1～ 180' (step 1')
。
－
，
＋
，
／－
＋
30‘85mm
2.0mm
0.07sec
5.0 ～ 10. 2mm
33.00 ‘ 67.500
0.00 - -15.000 ( 0.12/ 0.250)
2.0、12.0mm
Thermal printer
5. 15 Minutes
8inch ofTFT monitors
± 16mm (up and dom direction only)
AC 100 - 240V,50/ 60HZ/90W
484(L)X27 0( W) X450(H) mm 117KG
Max55mm
。
Auto Ref，帽ct meter
旦旦伊血直1
-20. •200 (V0•12) 0.12/0.250 Step
句iede,
m
言
Omm, 12mm,13 75mm
Sphe,ical
翩 翩
Veπe,distaace
8-•800.12月250st叩
Axis
0-1800 lO step
句icde,fo,m
Pupil distance
45-88mm, 1mm step
Min. pupil size
2.0mm
Keratome官y
。
Radius fcurvature
5.0.lOmm (inc『ement:O.Olmm)
c。meal Powe,
33.75-67.田O(when come，明ci,alent ,efracth,e inde,is 1.33可
c。meal astigmatism
削s
c。meal diametec
。
lnccemeot selectable from 0.1�0.250
1-1800jnccemenU O)
2.0 14mmQnc『·ement O 1mm)
。
Mem ryofdata
10 meatuce value f r each ,ightand lef飞f!Je
Cha"
Auto fog
。伽...
a川0帽U监erat
0.00 8.000Qnc,ement selectablefmm 0.12.0.250)
、
• conver IOfltusermt贸,u,ett,ng
• ,.,, b部揭帽，..α畸书andα>nltol
Oisplay
5.7' cc m LCO(FA-6800 &FA 6100A/6100吨， 5.6 Colo, LCO (FA 6000A)
P,im
The,mal p,inm
Powecsupp�
100 - 240V
Oimension
280mm (w),540mm(l),509 mm
目焰。”
，呻嗣同
• autof
Z
(H) (FA 680。）
280mm (w) ,492mm(L),462mm （呻（FA回OOA&FA 61田A/6100k)
Weight
22kg (FA 680町201<g (FA 6000A&FA 6100A/6100时
瞅 幽静 α
瞅 品
瞅 血
m
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m
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FA-series
lkeratometer
且町，阳『
mmm
且，Unel/keratometer
mm
。
www.sht pview.贷m
MORE PRODUCT
翩 翩
m
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旦旦伊且“1
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－�
Auto！！！堕理1些『
Near visi n test
Reverse side
7. Q-inch touch screen Aut
Features
• 7. 0-inch color LCD touch screen
• Stylish and compact design
• Auto detachment printer
• Independent PD adjustment
• Buill-in LED for near vision illuminati n
• Data transmission with auto refract meter and auto pr ector
。
S且here
Cylinder
Axls an2le
PUP-ii Distance
R tary Prism
Cross Cy_lmaer [ens
Retinoscope
。
IIII
II
I
II
II
。
Ph ropter Size
�豆豆
Power Box Size
Po苟言F言百
Fiil>f.』
mm.
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旦蹲监�，
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-19.00-+16.750吾250/0.500/1.000/3.00D steesl
-6. OOD-+6. OOD 0. 25D steps
。；；；1801{1'/5罩在再苟
Distant range 52-80mm Close range 48-76mm 0. 5门mm steps
。－206 0.1 /0.5 /1.06 steps
+Oj5日
+1.50D(67cm), +2.00D(50cm)
PH;: Binoculu纠 rt =1.0mmi
RMV、RMH
RL｛咱们!F!l、GL{Left 击5
Polaroid(Right eye 135。／45气Le何eye 45。／135。 ）
P时sm但！g!J!3玄B0,6玄BUlJLeft3玄BO, 10玄Bl)
Cross Cylinder Lens (±0.50D Axis=90。 ）
PD Lens
365mmx280mmx110mm 3.8kg
230mm叫95mmx190mm 1.2kli
236mmx126mmx115mm 2.1kg
瓦C220V 50Hz or AC110V 60Hz,90W
Auxiliary Lens
旦啤监
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电9
〈巨
Manual］！坦I盟堕E
min
r
跚跚跚�理堕
Elm
ManualPhoroPI时
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EIIm
MORE PRODUCT
融 融酣言
•H，＇，�l�咽·
S1it1am_11_
Five magn而cation
Eyepiece
12.5x
Total magn而cation
队10x 16x 25x 40x
Field of \Aew
Range of adjusting the distance of pupil
悟X: 33mm, 10X: 20mm, 16X: 13mm, 25X: 8mm, 40X :5mm
悟5 mm-75 mm
8D -+8口
0.794x
阳mm-14mm
1mm-14mm
Range of adjusting eyepieces
Magnification
Slit width
SI此length
Diamete「 of aperture
阳14mm,<p10mm，φ5mm,<p2mm,<p1mm， ψ0.2mm
阳－180
Slit angle
Filter
Bulb
怕， 5, 10, 15, 20
Heat absorption, Gre民red free(Green), Cobalt blue
1且，， 50w halogen bclb
Forwa「d and backward moving
阳0mm
Left and right moving
100mm
Illumination angle
V巾ving
15mm
Handle moving
Up and down moving
Uaw bracke Up and dawn moving
Fixation
part
Input voltage
Power
pomm
悔。mm
Red LED
11四220V士10%
Input f「equency
比0 60Hz
Input powe「
悟OVA
Output vo忧age
llumination: 4.5V 9V 12V
Fixation: 6V
EC601 - 1, type I of BF Model
Safe standard of electric
Packing box
阳e咀ht and
Gross weight
Dimension
Net weight
甘00mmx545mmx500mm
腔5Kg
位1Kg
t
Slitlamp
•m田节回
阳al阳o parallel style super叩tic
Type
Magnification change
阳icroscope
Slit lamp
1
旦旦伊且直
瞅
自却显
命
-
命
s1111amp
-
SLM-series
S-series
。
www.sht pview.贷m
Hand-held Digital Slit Lamp(Hyperion)
First portable digital slit lamp
High definition and stable image
Auto Focus
3.97 inch touch screen
MORE PRODUCT
1
且啤监置
ll'illi:!』
!
1，臼n be used叫ec川dren, the elder川conveni叫。move the patie
2, for veterinary medicine
。
3, for f rensic investigation site
Portables1111amp
mmm
Light bulbswith a high degree ofwhite LED, long life;
Configuration rechargeable lithium battery, each charge臼n be used 5-6 hours;
Light and sma忧，weighing only 750 grams;
Hand-held slit lamp microscope eyepiecewith linkage function, andwith four spots;
Sets the topic of desktop slit lamp function, is theworld ’s first;
Can be upgraded to digital handheld slit lamp microscope.
1
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旦旦伊直直
旦理血直
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Portables！川”－
川，bles刷mo
-
阳ableslit
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M睛
一
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”蛐1lmicASCAN
IDB
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mmm
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m阳帽，und回anner
二二二
UBM
笔墨
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c9
，，，
Colo『 non-mydriatic color.Red F 『ee
LCD
45 。 max
Mydriatic: 5.1 mm or more Non-Mydriatic: 3.3mm or
more
Imaging device
DSLR
Sensor
18.0 Meaapixels
Diopter compensation
士20D
Working distance
42mm
Fixation target
LED green
Base movement
60 mm front and back, 11O mm side to side, 30 mm
up and down
Panning range
30 degrees to the right and left
Tilting range
15degrees up, 1O degrees down
Power supply
AC 220V 50/60 Hz
Operating environment
Temperature: 10。 c to 35。C Humidity: 30% RH to
80%RH
Types of photography
Retinal obse 『vation
Angle of view
Minimum pupil size
TNF-506
’
Types of photog『aphy
Angle of view
Workina distance
Retinal obse 『vation
Minimum pupil size
移
lmaaina device
Senso『
Fixation ta『口et
Dioote『 comoensation
Focusin口 mode
Disolav mode
Base movement
Pannina 『anae
Tiltin口『an口e
Powe『 supply
Operating environment
TNF-507
APS-AER
Color,non-mydriatic color,FFA, Red F『ee
50 • max
42mm
LCD
Mydriatic: 5.1 mm or more
Non-Mvdriatic: 3.5 mm o『 more
DSLR
18.0 Meaaoixels
LED
+200
Double dot auxilia 『V focusina
Double-screen disolav
80mm front and back 100 mm side to side
30de口『ees to the riaht and left
15 de口『ees u口 10 de口『ees down
AC 220V 50/60 Hz
『
1 cto 35。C
i% o·
RH to 80% RH
，
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Field Seo口e
Uo to 53 dea 『ee
Wo『kina distance
40mm
Supportina
Non mvdratic Camera
Minimum ouoil diamete『
13.3 『『1『n
Obse 『vation liahtsou『ce
Infra『ed liaht
Ref 『active comoensation ranae 12'±150
Extemal fixation
Fixation
:, Internal fixation(9 internal fixation ootionall
Assisted Alianment
Two round dots alianment
Focus wav
Manual Auto
Exposu『e way
Manual.Auto
Internet inte『face
Dicom 3.0 interface. Lan(Ootional)
The second viewin口 screen
Ootional /7"LCDl
Eve position 『ecoanition
队uto
Workina distance
Horizontal±30 dea 『ee uo and down +12.5 de口『ee
Workina distance
同2mm±2mm
Moto-table
Electric Moto-table
workstation
Electric Moto-table
Hiah 口ualitvinkiet orinte『
orinte 『
Field Scope
WV，。rkina distance
Non-mvdratic Camera
Minimum 口U口ii diameter
Fundus fluorescein anaioaraphy
bservation liaht source
Refractive comoensation ranae
。
tr APS-BER
，
Fixation
队ssisted Alianment
Focuswav
Exposure wav
Internet interface
The second viewina screen
Eye p。 srtion rec。口nrtion
w。 rkina distance
叭lorkina distance
Mato-table
iworkstation
lorinter
Up to 53 dearee
40m付1
Suooortina
3.3mm
Flash and dynamic anaioaraphy
Infrared liaht
主变 150
External fixation
5 Internal fixation(9 internal fixation o口 tional)
Two round dots alianment
Manual Auto
Manual Auto
Dicom 3.0 interface, Lan(Optionall
Optional (?"LCD}
16.uto
Hor恒ontal士30 dearee uo and down +12.5 decree
42付，m士2mm
Electric Mot。－ table
Electric Moto-table
Hiah aualrtv inkiet orinter
。
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