Identity
- Trade Name
- Accu-Beam FDA UDI
- Generic Name
- Surgical laser system beam-focus handpiece FDA UDI
- Device Name
- F200mm CO2 Laser Handpiece. FDA UDI
- Model / Reference
- 6108 FDA UDI
- Description
- F200mm CO2 Laser Handpiece. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B17761080 FDA UDI
- 510(k) Number
- K945648 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Surgical laser system beam-focus handpiece 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical laser system beam-focus handpiece
Accu-Beam by Transamerican Technologies International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical laser system beam-focus handpiece.
- SurgiTouch™ Scanning Handpiece 260mm — Lumenis Be, Inc. · Class II
- SurgiTouch™ Scanning Handpiece 125mm — Lumenis Be, Inc. · Class II
- TrueSpot™ 2.0mm Handpiece — Lumenis Be, Inc. · Class II
- UltraPulse® SurgiTouch™ Upgrade Kit — Lumenis · Class II
- SurgiTouch™ Scanning Handpiece Set — Lumenis Be, Inc. · Class II
- AcuPulse Incisional Handpiece 125 mm — Lumenis Be, Inc. · Class II
- Multi-Application Handpiece Set — Lumenis · Class II
- SurgiTouch™ Scanning Handpiece 200mm — Lumenis Be, Inc. · Class II
Cleared under the same submission
K945648 also covers:
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
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
- Transamerican Technologies International
Sources (1)
- FDA UDI 6efa6880-d23e-40d0-ae51-5d559ace4b35 34 fields · synced Jun 9, 2026