Identity
- Trade Name
- HAIR REMOVAL LASER FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Model / Reference
- HRL 4X FDA UDI
Identifiers
- Catalog Number
- 3724 FDA UDI
- Primary DI / UDI-DI
- G7433724 FDA UDI
- 510(k) Number
- K090820 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
No
FDA UDI
Over-the-Counter
Yes
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: Dermatological diode laser system
Hair Removal Laser by Tria Laser Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological diode laser system.
- Emerge Handpiece — Cynosure, LLC · Class II
- GSD — Shenzhen GSD Tech Co., Ltd. · Class II
- VIKINI Laser H/P — ILOODA.CO., LTD · Class II
- Diode Laser Therapy Machine — Beijing ADSS Development Co., Ltd. · Class II
- DioBreeze — FORMATK SYSTEMS LTD · Class II
- TwinScan 808/755 Laser System — GME German Medical Engineering GmbH · Class II
- Darwin RF Thermal — Luvo Medical Technologies Inc · Class II
- Diode 810nm2 cm2 HP — ALMA LASERS LTD. · Class II
Cleared under the same submission
K090820 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tria Laser Inc
Sources (1)
- FDA UDI cd71f246-6b7b-4f68-8cea-ba04445af6a3 35 fields · synced May 30, 2026