Identity
- Trade Name
- ZHEONE FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Device Name
- The Diode laser therapy device is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. FDA UDI
- Model / Reference
- FD-L01 FDA UDI
- Description
- The Diode laser therapy device is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06977620360002 FDA UDI
- 510(k) Number
- K232709 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatological diode laser system
Zheone by Hebei Zhemai Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological diode laser system.
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- HAIR REMOVAL LASER — TRIA LASER INC · Class II
- HAIR REMOVAL LASER — TRIA LASER INC · 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
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
- Hebei Zhemai Technology Co., Ltd.
Sources (1)
- FDA UDI 7a63a9e2-5f56-47e4-a1da-a03ffdeee072 34 fields · synced May 30, 2026