Identity
- Trade Name
- Sheerwave EUDAMEDExtra FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- Extra EUDAMEDHair removal device FDA UDI
- Model / Reference
- 618 EUDAMEDIPL-360 EUDAMED818 FDA UDI
- Description
- Hair removal device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016727043 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290016727043 EUDAMED
- 510(k) Number
- K050950 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Category: Red-light phototherapy unit, professional
Sheerwave by Active Optical Systems Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Red-light phototherapy unit, professional.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07290016727043 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Active Optical Systems Ltd
- EUDAMED SRN
- IL-MF-000024754
- Authorised Representative
- QS MEDICAL DEVICE REGISTRATION LTD CY-AR-000024665
Sources (2)
- EUDAMED 3ec38623-a265-468a-9a2d-b05e5de058f4 61 fields · synced Jul 16, 2026
- FDA UDI f849313a-3f17-41a1-a821-c2fdc1db3a08 35 fields · synced May 30, 2026