Identity
- Trade Name
- WONTECH Surgical Optic Fibers FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, single-use FDA UDI
- Device Name
- BA400 of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R) FDA UDI
- Model / Reference
- BA400 FDA UDI
- Description
- BA400 of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800022301800 FDA UDI
- 510(k) Number
- K241643 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General/multiple surgical laser system beam guide, single-use
WONTECH Surgical Optic Fibers by Wontech Co., Ltd — 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.
- Moses™ — Lumenis · Class II
- 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
- SlimLine™ 200 D/F/L LP — Lumenis · Class II
- Dornier MedTech — Dornier MedTech GmbH · Class II
- Olympus — Gyrus Acmi, Inc. · Class II
- Dornier MedTech — Dornier MedTech America, Inc. · Class II
Cleared under the same submission
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
- Wontech Co., Ltd
Sources (1)
- FDA UDI 9cfb5a63-682e-4b58-9155-1e58d38d76ab 34 fields · synced May 30, 2026