Identity
- Trade Name
- 90° Mirror Tip for Multi-Application Ha FDA UDI
- Generic Name
- General/multiple surgical carbon dioxide laser system FDA UDI
- Model / Reference
- NA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290117771457 FDA UDI
- 510(k) Number
- K212703 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical carbon dioxide laser system 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General/multiple surgical carbon dioxide laser system
90° Mirror Tip for Multi-Application Ha by Lumenis Be, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General/multiple surgical carbon dioxide laser system.
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- DEKA SMARTXIDE TETRA — EL.EN. SPA · Class II
- BVLASER — Nanjing Bestview Laser S&T Co., Ltd. · Class II
- Bestview — Zhengzhou Bestview ST Co., Ltd. · Class II
- SMARTXIDE TETRA PRO — DEKA M.E.L.A. SRL · Class II
Cleared under the same submission
K212703 also covers:
- 120° 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.
- SurgiTouch™ Scanning Handpiece Set — 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 14d166ac-b3ad-406f-8239-f0724e511751 33 fields · synced May 30, 2026