Identity
- Trade Name
- enlighten SR EUDAMEDenlighten FDA UDI
- Generic Name
- Dermatological frequency-doubled solid-state laser system FDA UDI
- Device Name
- enlighten SR EUDAMEDenlighten Family EUDAMEDenlighten SR Laser System FDA UDI
- Model / Reference
- ENLIGHTENSR EUDAMEDenlighten SR FDA UDI
- Description
- enlighten SR Laser System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816722021625 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816722021625 EUDAMED00816722021600DC EUDAMED
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011019 MULTI–PLATFORM LASER EUDAMED
- GMDN Term
- Dermatological frequency-doubled solid-state laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
enlighten SR by Cutera, Inc. — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00816722021625 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00816722021625 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Cutera, Inc.
- EUDAMED SRN
- US-MF-000010456
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 26c035f4-4cfc-40c9-a13e-7110ccca22ce 61 fields · synced Aug 1, 2026
- EUDAMED 961d3cb0-8f83-40ff-9536-af18a0a89dd7 61 fields · synced May 19, 2026
- FDA UDI fbb02a6d-8c87-4b16-830b-b83e6e126cb6 34 fields · synced May 30, 2026