Identity
- Trade Name
- AvalancheLase FDA UDI
- Generic Name
- Dermatological solid-state laser system FDA UDI
- Device Name
- The AvalancheLase Family is based on Nd:YAG (1064 nm) and Alexandrite (755 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamp pumped laser sources in one housing, with optical cavities containing the Nd:YAG and Alexandrite crystals. A green diode aiming beam (520 nm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical manual handpiece or scanner. The AvalancheLase Family is designed to operate in single wavelength (Nd:YAG or Alexandrite) configurations (models) and dual wavelength (Nd:YAG and Alexandrite) configurations (models). FDA UDI
- Model / Reference
- M071-2F/XP FDA UDI
- Description
- The AvalancheLase Family is based on Nd:YAG (1064 nm) and Alexandrite (755 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamp pumped laser sources in one housing, with optical cavities containing the Nd:YAG and Alexandrite crystals. A green diode aiming beam (520 nm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical manual handpiece or scanner. The AvalancheLase Family is designed to operate in single wavelength (Nd:YAG or Alexandrite) configurations (models) and dual wavelength (Nd:YAG and Alexandrite) configurations (models). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03830054230385 FDA UDI
- 510(k) Number
- K223540 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological solid-state 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatological solid-state laser systemMulti-modality skin surface treatment system generator
AvalancheLase by Fotona D.O.O. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Fotona D.O.O.
Sources (1)
- FDA UDI 43f69801-2b4e-4fc2-b56c-1fe6e4351f53 35 fields · synced Jun 8, 2026