Identity
- Trade Name
- Optilite FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, single-use FDA UDI
- Device Name
- 600 micron single-use fiber assembly with flat tip FDA UDI
- Model / Reference
- OPT1060F FDA UDI
- Description
- 600 micron single-use fiber assembly with flat tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855430006791 FDA UDI
- 510(k) Number
- K211517 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical laser system beam guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
No
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
Hydrogen Peroxide FDA UDI
Category: General/multiple surgical laser system beam guide, single-use
Optilite by Convergent Laser Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General/multiple surgical laser system beam guide, single-use.
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- Dornier MedTech — Dornier MedTech GmbH · Class II
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- Dornier MedTech — Dornier MedTech America, Inc. · Class II
Cleared under the same submission
K211517 also covers:
- Optilite — Convergent Laser Technologies
- Optilite — Convergent Laser Technologies
- Optilite — Convergent Laser Technologies
- Optilite — Convergent Laser Technologies
- Optilite — Convergent Laser Technologies
- Optilite — Convergent Laser Technologies
- Optilite — Convergent Laser Technologies
- Optilite — Convergent Laser Technologies
- Optilite — Convergent Laser Technologies
- Optilite — Convergent Laser Technologies
- Optilite — Convergent Laser Technologies
- Optilite — Convergent Laser Technologies
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Convergent Laser Technologies
Sources (1)
- FDA UDI 7e70c3c5-162f-4e5f-b32d-11a5fbaae670 35 fields · synced May 30, 2026