Identity
- Trade Name
- SurgiTouch™ Scanning Handpiece Set FDA UDI
- Generic Name
- Surgical laser system beam-focus handpiece FDA UDI
- Device Name
- Direct Marking (DM): 07290117771402, 07290117771426, 07290117771419, 07290117771952, 07290117771969, 07290117771976, 07290117771983, 07290117771990, 07290117772003, 07290117772010, 07290117772027, 07290117772034. . , ., , FDA UDI
- Model / Reference
- NA FDA UDI
- Description
- Direct Marking (DM): 07290117771402, 07290117771426, 07290117771419, 07290117771952, 07290117771969, 07290117771976, 07290117771983, 07290117771990, 07290117772003, 07290117772010, 07290117772027, 07290117772034. . , ., , FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290117771396 FDA UDI
- 510(k) Number
- K212703 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical laser system beam-focus handpiece
SurgiTouch™ Scanning Handpiece Set by Lumenis Be, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical laser system beam-focus handpiece.
- Accu-Beam — Transamerican Technologies International · Class II
- Accu-Beam — Transamerican Technologies International · Class II
- Accu-Beam — Transamerican Technologies International · Class II
- Accu-Beam — Transamerican Technologies International · Class II
- UltraPulse® SurgiTouch™ Upgrade Kit — Lumenis · Class II
- Accu-Beam — Transamerican Technologies International · Class II
- Accu-Beam — Transamerican Technologies International · Class II
- Accu-Beam — Transamerican Technologies International · Class II
Cleared under the same submission
K212703 also covers:
- 120° Mirror Tip for Multi-Application Ha — Lumenis Be, Inc.
- 90° Mirror Tip for Multi-Application Ha — Lumenis Be, Inc.
- AcuPulse Incisional Handpiece 125 mm — Lumenis Be, Inc.
- SurgiTouch™ Scanning Handpiece 125mm — Lumenis Be, Inc.
- SurgiTouch™ Scanning Handpiece 200mm — Lumenis Be, Inc.
- SurgiTouch™ Scanning Handpiece 260mm — Lumenis Be, Inc.
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 Be, Inc.
Sources (1)
- FDA UDI 49a52255-f6a5-45df-b9c7-0cabb8c6472d 34 fields · synced Jun 8, 2026