Identity
- Trade Name
- Bare Fiber 2.1 1000 FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, single-use FDA UDI
- Device Name
- Single use optical fiber for surgery FDA UDI
- Model / Reference
- 2958 FDA UDI
- Description
- Single use optical fiber for surgery FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04058784000460 FDA UDI
- 510(k) Number
- K161257 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
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
No
FDA UDI
Category: General/multiple surgical laser system beam guide, single-use
Bare Fiber 2.1 1000 by Asclepion Laser Technologies GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K161257 also covers:
- Bare Fiber 2.1 200 — Asclepion Laser Technologies GmbH
- Bare Fiber 2.1 400 — Asclepion Laser Technologies GmbH
- Bare Fiber 2.1 600 — Asclepion Laser Technologies GmbH
- Bare Fiber 2.1 800 — Asclepion Laser Technologies GmbH
- Bare Fiber B 2.1 272 — Asclepion Laser Technologies GmbH
- Bare Fiber B 2.1 365 — Asclepion Laser Technologies GmbH
- Bare Fiber B 2.1 550 — Asclepion Laser Technologies GmbH
- Bare Fiber B R 2.1 272 — Asclepion Laser Technologies GmbH
- Bare Fiber B R 2.1 365 — Asclepion Laser Technologies GmbH
- Bare Fiber B R 2.1 550 — Asclepion Laser Technologies GmbH
- Bare Fiber R 2.1 1000 — Asclepion Laser Technologies GmbH
- Bare Fiber R 2.1 200 — Asclepion Laser Technologies GmbH
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
- Asclepion Laser Technologies GmbH
Sources (1)
- FDA UDI d5231139-6ee3-450c-af16-bcc1922b1cc2 35 fields · synced May 31, 2026