Identity
- Trade Name
- ERISE Laser Handpiece FDA UDI
- Generic Name
- Dermatological solid-state laser system FDA UDI
- Device Name
- ERISE Laser Handpiece is an Erbium:YAG laser handpiece delivering laser radiation at 2940nm. It is intended to be used with DEKA LUXEA platform, cleared by FDA with K192539. The ERISE Laser Handpiece includes: - a connector to connect to the console - a cord where electrical cables and hydraulic tubes pass in - a plastic shell - a laser cavity - a mechanical shutter - an optical guide - an ending tip which provides different spot sizes (diameter 2, 4, 9mm), including microbeam output (diameter 9mm). The 2940nm Erbium:YAG laser handpiece is controlled by the DEKA LUXEA console which it is connected to, through the connector. FDA UDI
- Model / Reference
- E262B1 FDA UDI
- Description
- ERISE Laser Handpiece is an Erbium:YAG laser handpiece delivering laser radiation at 2940nm. It is intended to be used with DEKA LUXEA platform, cleared by FDA with K192539. The ERISE Laser Handpiece includes: - a connector to connect to the console - a cord where electrical cables and hydraulic tubes pass in - a plastic shell - a laser cavity - a mechanical shutter - an optical guide - an ending tip which provides different spot sizes (diameter 2, 4, 9mm), including microbeam output (diameter 9mm). The 2940nm Erbium:YAG laser handpiece is controlled by the DEKA LUXEA console which it is connected to, through the connector. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08034108512426 FDA UDI
- 510(k) Number
- K202258 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
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
Category: Dermatological solid-state laser system
ERISE Laser Handpiece by Deka M.e.l.a. Srl — 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
- Deka M.e.l.a. Srl
Sources (1)
- FDA UDI 8850500f-b8a6-4915-bf54-e2b59c8c736c 34 fields · synced Jun 9, 2026