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SS FiberLase™ Accessory Starter Kit with FiberLase Fiber
FDA UDIClass II (US FDA UDI)
by Lumenis
Identity
- Trade Name
- SS FiberLase™ Accessory Starter Kit with FiberLase Fiber FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, single-use FDA UDI
- Model / Reference
- SS FiberLase™ Accessory Starter Kit with FiberLase Fiber FDA UDI
Identifiers
- Catalog Number
- KT-2064910 FDA UDI
- Primary DI / UDI-DI
- 07290109142517 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General/multiple surgical laser system beam guide, single-use
SS FiberLase™ Accessory Starter Kit with FiberLase Fiber by Lumenis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General/multiple surgical laser system beam guide, single-use.
- Flexiva Pulse — Boston Scientific · Class II
- InnoVoyce Laser Fiber — InnoVoyce LLC · Class II
- Trimedyne® OmniTip™ - 30 cm Side Firing Switchable Tip with Suction/Irrigation — TRIMEDYNE, INC. · Class II
- Dornier MedTech — Dornier MedTech GmbH · Class II
- Olympus — Gyrus Acmi, Inc. · Class II
- Dornier MedTech — Dornier MedTech America, Inc. · Class II
- neoLaser Laser Surgery Fiber — G.N.S Neolaser , Ltd. · Class II
- InnoVoyce Laser Fiber — InnoVoyce LLC · Class II
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
- Lumenis
Sources (1)
- FDA UDI 255003d1-af48-4b92-a9ba-d91842f430f0 34 fields · synced Jun 1, 2026