Identity
- Trade Name
- CLARITY II FDA UDI
- Generic Name
- Dermatological solid-state laser system FDA UDI
- Device Name
- TIP PACKAGE_USA FDA UDI
- Model / Reference
- TIP PACKAGE FDA UDI
- Description
- TIP PACKAGE_USA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809447657721 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatological solid-state laser system
Clarity Ii by Lutronic Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological solid-state laser system.
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- Canister HFC-134a /980g, ALUM, 15 pack — Candela Corporation · Class II
- GentleYAG — Candela Corporation · Class II
- GMAX Pro Plus Laser System — Candela Corporation · Class II
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
- Lutronic Corporation
Sources (1)
- FDA UDI 3bf8bb43-e79e-4bd2-98ea-c262fb0ab8fb 35 fields · synced May 29, 2026