Identity
- Trade Name
- Anchorfree FDA UDI
- Generic Name
- Dermatological solid-state laser system FDA UDI
- Device Name
- The diode laser system is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch. The proposed system provides two working modes, which are standard hair removal mode (HR) and fast hair removal mode (FHR). They are different in the combination of frequency and fluence. Compared with HR mode, the FHR Mode (Fast Hair Removal) has low fluence and high repetition rate (10Hz). The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black); in addition, the treatment can also be applied to different parts of the body, including Axillary, Chest, Arm, Back, Leg, Hairline, Cheek, Lip, Beard, and Bikini. FDA UDI
- Model / Reference
- L808 FDA UDI
- Description
- The diode laser system is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch. The proposed system provides two working modes, which are standard hair removal mode (HR) and fast hair removal mode (FHR). They are different in the combination of frequency and fluence. Compared with HR mode, the FHR Mode (Fast Hair Removal) has low fluence and high repetition rate (10Hz). The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black); in addition, the treatment can also be applied to different parts of the body, including Axillary, Chest, Arm, Back, Leg, Hairline, Cheek, Lip, Beard, and Bikini. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970441320019 FDA UDI
- 510(k) Number
- K141973 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatological solid-state laser system
Anchorfree by Beijing Anchorfree Technology Co., Ltd. — 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
- Beijing Anchorfree Technology Co., Ltd.
Sources (1)
- FDA UDI b7733dde-847f-47f8-9538-1978964ebd34 34 fields · synced May 29, 2026