Identity
- Trade Name
- Shenzhen Wells Optoelectronics Co.,Ltd. FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- derma pen/DZ01 FDA UDI
- Model / Reference
- DZ01 FDA UDI
- Description
- derma pen/DZ01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06977182810113 FDA UDI
- FDA Product Code
- KNM FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5765 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multi-modality skin surface treatment system
Shenzhen Wells Optoelectronics Co., Ltd. by Shenzhen Wells Optoelectronics Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-modality skin surface treatment system.
- Deep2 — Termosalud · Class I
- 2941 handpiece — Cynosure, LLC · Class II
- Isolaz — Solta Medical, Inc. · Class II
- Handpiece 570 (6.4) for Harmony XL — ALMA LASERS LTD. · Class II
- Tip ClearLift QS KTP 532 4mm (Female) — ALMA LASERS LTD. · Class II
- ClearLift Depth Control Set for ClearLift QS 5x5 (No Lasing Tip) Female — ALMA LASERS LTD. · Class II
- OXYLIGHT — RAJA Medical · Class II
- 2940 handpiece — Cynosure, LLC · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Wells Optoelectronics Co., Ltd.
Sources (1)
- FDA UDI e5d21060-de8c-4f05-bc3e-2da6f8dfb190 33 fields · synced Jun 8, 2026