Identity
- Trade Name
- elysion-pro FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Device Name
- ELYSION diode laser hair removal system with 755nm and 810nm and applicators include: • Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. • Treatment of Pseudofolliculitis barbae (PFB) FDA UDI
- Model / Reference
- ELYSION diode laser hair removal system FDA UDI
- Description
- ELYSION diode laser hair removal system with 755nm and 810nm and applicators include: • Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. • Treatment of Pseudofolliculitis barbae (PFB) FDA UDI
Identifiers
- Catalog Number
- 522040 FDA UDI
- Primary DI / UDI-DI
- 08437020651141 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological diode 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 diode laser system
elysion-pro by High Technology Products Sl — 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
- High Technology Products Sl
Sources (1)
- FDA UDI 6e6297b5-8820-4d9f-b4a1-6cfa0e962f55 35 fields · synced Jun 7, 2026