Identity
- Trade Name
- excel HR EUDAMEDFDA UDI
- Generic Name
- Dermatological solid-state laser system FDA UDI
- Device Name
- excel HR EUDAMEDexcel Family EUDAMEDexcel HR Laser System FDA UDI
- Model / Reference
- EXCELHR EUDAMEDexcel HR FDA UDI
- Description
- excel HR Laser System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816722021502 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816722021502 EUDAMED00816722021300CV EUDAMED
- 510(k) Number
- K132185 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011019 MULTI–PLATFORM LASER EUDAMED
- GMDN Term
- Dermatological 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
excel HR 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-00816722021502 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00816722021502 | 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 851af1ec-b83c-4a0b-be49-8038752bdfb6 61 fields · synced Jul 17, 2026
- EUDAMED 324ffe4f-f989-4655-becc-a336e99368f5 61 fields · synced May 19, 2026
- FDA UDI 0a5d11aa-3170-4277-aa79-2a41f5d0f4e7 35 fields · synced May 30, 2026