FDA.reportPublic FDA data

SUPER VIEW® Disposable Lens Set

Primary DI
00856222004001
Brand
SUPER VIEW® Disposable Lens Set
Company
OCULUS SURGICAL INC
Model
40411
Catalog number
40411
Device description
SUPER VIEW® Sterile Lens Pack for use with the SUPER VIEW® System and the BIOM®
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJKLens, Contact, Polymethylmethacrylate, DiagnosticOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051630000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051630000SUPER VIEW DISPOSABLE BIOM LENS SETInsight Instruments, Inc.2005-06-29HJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856222004008PackageGS120In Commercial Distribution
00856222004001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085622200400810856222004008
00856222004001008562220040018562220040010856222004001

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic condensing lensAn ophthalmic lens used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) to focus reflected light from the fundus of the eye. Compared to direct ophthalmosocoy, the indirect method enables better viewing of the peripheral region of the fundus out to the ora serrata (serrated junction between the retina and the ciliary body).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter13Millimeter
Outer Diameter18Millimeter
Outer Diameter42Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(772) 236-2622sales@oculussurgical.com
(772) 236-2622info@oculussurgical.com

Regulatory Flags#

DUNS number
015409582
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856222004025SUPER VIEW® Pack40211402112016-09-23
00856222004728HD LenZ Pack Plus, for ZEISS RESIGHT®54019540192020-11-24
00856222004018SUPER VIEW® Pack40213402132016-09-23
00856222004209SUPER VIEW Lens, Disposable Contact, Tornambe40413404132024-08-13
10856222004206SUPER VIEW Lens, Disposable Contact, Tornambe40413404132024-08-13
00852475007042SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®40240402402020-11-24
00852475007103HD LenZ Pack for ZEISS RESIGHT®54010540102020-11-24
00852475007127BIOM Optic Set, HD Professional, for f=175mm54021540212022-02-15
00852475007141BIOM Optic Set, HD Professional, for f=200mm54022540222022-02-15
00852475007165HD Disposable, LenZ54026540262022-02-15
00852475007240Versa Optic Set, for f=200mm54212542122022-01-25
00852475007264VERSA HD Disposable LenZ542162020-12-04
00856222004056SUPER VIEW® Disposable Lens Set, Essential40403404032016-09-23
00856222004179SUPER VIEW® Disposable Lens Set, Pivot Plus40227402272016-09-23
00856222004544SUPER VIEW® Disposable HD Lens Set for RESIGHT®40220402202020-11-24
00856222004551SUPER VIEW Pack, HD, Disposable, for ZEISS RESIGHT®54018540182020-11-24
00856222004742SUPER VIEW® Disposable Lens Set, Pivot40223402232016-09-23
00852475007158BIOM Optic Set, HD Flex54025540252022-02-15
00852475007219Versa Optic Set, for f=175mm54211542112022-01-25
00852475007080Super View® Pack, Pivot Plus (40101+40227)40229402292020-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841668123942KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00841668144466KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00841668144473KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668123949KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668144463KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668144470KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00818806021774RxSight Contact LensRXSIGHT, INC.HJK2025-09-05
00811608014869Capsulotomy (VLUCAPS)VOLK OPTICAL INC.HJK2025-01-29
00811608015934Iridectomy (VLUIRID)VOLK OPTICAL INC.HJK2025-01-29
00856222004209SUPER VIEW Lens, Disposable Contact, TornambeOCULUS SURGICAL INCHJK2024-08-13
10856222004206SUPER VIEW Lens, Disposable Contact, TornambeOCULUS SURGICAL INCHJK2024-08-13
00811608014654Single Use Indirect Wide Field (VVITSSVDH)VOLK OPTICAL INC.HJK2023-10-19
10811608014675Single Use Indirect Wide Field (VVITSSVDH)VOLK OPTICAL INC.HJK2023-10-19
03760087122343SINGLE USE 3 MIRRORS CONTACT LENSFCI S A S FCI 20 22HJK2021-05-30
00852475007202"Contact Lens, HD Professional, Cohen-Benner, ""CBC"""OCULUS SURGICAL INCHJK2021-02-26
10852475007209Contact Lens, HD Professional, Cohen-Benner, "CBC"OCULUS SURGICAL INCHJK2021-02-26
00852475007042SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®OCULUS SURGICAL INCHJK2020-11-24
00852475007059SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®OCULUS SURGICAL INCHJK2020-11-24
00818806020531RxSight Contact LensRXSIGHT, INC.HJK2020-10-16
03760087122176Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087122190Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087122206Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087122213Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087123685Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087123692Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087123708Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122171Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122195Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122201Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122218Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06