AF Laser
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- AF Laser EUDAMED
- Device Name
- AF Laser EUDAMED
- Model / Reference
- AF Laser EUDAMEDNon-invasive laser EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800017100531 EUDAMED
- Basic UDI-DI
- 88000171SH013CB EUDAMED
- 510(k) Number
- K221363 FDA 510(k)
- FDA Product Code
- PDZ FDA 510(k)
- EMDN Code
- Z120615 THERAPEUTIC LASERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Market of Registration
- Poland EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The AF Laser is a Laser for Temporary Increase of Clear Nail in Patients with Onychomycosis, classified as a Class II medical device. It emits targeted laser energy to improve nail transparency and appearance in individuals affected by fungal nail infections, aiding in cosmetic and functional outcomes during treatment.
This device is supplied as a reusable medical instrument, intended for use in clinical settings by trained professionals. It operates under FDA 510(k) clearance and MDR compliance, with regulatory classification under 878.4810. Sterilization and maintenance protocols must adhere to manufacturer guidelines to ensure safe, repeated use in dermatological or plastic surgery environments.
Frequently asked questions
What is the primary purpose of the AF Laser in clinical settings?
The AF Laser is designed to temporarily improve nail transparency and appearance in patients with onychomycosis (fungal nail infections). By emitting targeted laser energy, it helps enhance cosmetic and functional outcomes during treatment, making nails clearer and more aesthetically pleasing while the infection is being addressed.
Is the AF Laser intended for single-use or repeated use in a clinical environment?
The AF Laser is supplied as a reusable medical instrument, meaning it is meant for repeated use in clinical settings by trained professionals. However, it must be sterilized and maintained according to the manufacturer’s guidelines to ensure safety and functionality between uses.
How is the AF Laser regulated, and what does its classification mean for its use?
The AF Laser is classified as a Class II medical device under FDA 510(k) clearance and MDR compliance, with a regulatory classification of 878.4810. This classification indicates it has undergone a review to ensure it is substantially equivalent to a predicate device, allowing it to be used in dermatological or plastic surgery environments for its intended purpose.
What type of professional training or expertise is required to operate the AF Laser?
The AF Laser is intended for use by trained professionals in clinical settings, such as dermatologists or plastic surgeons. While the device itself does not require specialized certification beyond standard medical device operation, familiarity with laser therapy and nail treatment protocols is implied to ensure safe and effective use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221363 | Class II | Active |
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Manufacturer
- Manufacturer
- shenb Co., Ltd.
Sources (2)
- FDA 510(k) K221363 24 fields · synced Sep 18, 2026
- EUDAMED 4fb713ad-cc89-4533-a574-bcbe5d568284 61 fields · synced Jul 25, 2026