Identity
- Trade Name
- SUPER VIEW® Disposable Lens Set for RESIGHT® FDA UDI
- Generic Name
- Vitrectomy contact lens, single-use FDA UDI
- Device Name
- 1 Each RESIGHT® Wide Field Lens and 1 Each Hassan-Tornambe Contact Lens FDA UDI
- Model / Reference
- 40219 FDA UDI
- Description
- 1 Each RESIGHT® Wide Field Lens and 1 Each Hassan-Tornambe Contact Lens FDA UDI
Identifiers
- Catalog Number
- 40219 FDA UDI
- Primary DI / UDI-DI
- 00856222004049 FDA UDI
- 510(k) Number
- K051630 FDA UDI
- FDA Product Code
- HJK FDA UDI
- GMDN Term
- Vitrectomy contact lens, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1385 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 13 Millimeter FDA UDIOuter Diameter — 18 Millimeter FDA UDI
Category: Ophthalmic diagnostic condensing lensVitrectomy contact lens, single-use
SUPER VIEW® Disposable Lens Set for RESIGHT® by Insight Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vitrectomy contact lens, single-use.
- MAGNIFIER LENS — Katena Products, Inc. · Class II
- PHAKOS — Phakos · Class II
- Irrigating Contact Lens — ESCALON MEDICAL CORP · Class I
- HD LenZ Pack for ZEISS RESIGHT® — OCULUS SURGICAL INC · Class II
- PHAKOS — Phakos · Class II
- Disposable 30 Deg. Vitrectomy — OCULAR INSTRUMENTS, INC. · Class II
- Disposable Direct Image 1.5x Mag (VMD) — VOLK OPTICAL INC. · Class II
- PHAKOS — Phakos · Class II
Cleared under the same submission
K051630 also covers:
- SUPER VIEW® Disposable Lens Set for ZEISS RESIGHT® — INSIGHT INSTRUMENTS, INC.
- Contact Lens, HD Professional, Cohen-Benner, "CBC" — OCULUS SURGICAL INC
- SUPER VIEW Lens, Disposable Contact, Tornambe — OCULUS SURGICAL INC
- SUPER VIEW® Disposable Lens Set — OCULUS SURGICAL INC
- SUPER VIEW® Disposable Lens Set, Pivot Plus — OCULUS SURGICAL INC
- SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT® — OCULUS SURGICAL INC
- SUPER VIEW® Lens, Disposable Contact, Hassan-Tornambe — OCULUS SURGICAL INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Insight Instruments, Inc.
Sources (1)
- FDA UDI 23811077-7247-44c5-b347-3e31ea684f56 38 fields · synced May 30, 2026