Identity
- Trade Name
- Navilas Zero Power Laser Lens FDA UDI
- Generic Name
- Laser lens, ophthalmic, surgical FDA UDI
- Model / Reference
- OD-OS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630238108751 FDA UDI
- 510(k) Number
- K863911 FDA UDI
- FDA Product Code
- HJK FDA UDI
- GMDN Term
- Laser lens, ophthalmic, surgical 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
High-level Disinfectant FDA UDI
Category: Laser lens, ophthalmic, surgical
Navilas Zero Power Laser Lens by Ocular Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K863911 also covers:
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
- Ocular Instruments, Inc.
Sources (1)
- FDA UDI 983bd202-aa02-459f-8198-8d4157591a25 33 fields · synced May 30, 2026