Identifiers
- 510(k) Number
- K231321 FDA 510(k)
- FDA Product Code
- OAP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5500 FDA 510(k)
- Regulation Number
- 890.5500 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nooance LED and Laser Helmet is a Class 2 laser comb device designed for hair growth stimulation. It combines light-emitting diodes (LEDs) and laser technology to target hair follicles, promoting cellular activity in the scalp for potential hair restoration.
This device is intended for use in clinical settings under professional supervision, supplied as a reusable medical instrument. It operates under FDA 510(k) clearance (K231321) and adheres to regulatory standards outlined in 21 CFR 890.5500. No specific sterility or MRI safety information is provided in the data.
Frequently asked questions
What is the primary purpose of the Nooance LED and Laser Helmet, and where is it intended to be used?
The Nooance LED and Laser Helmet is designed for hair growth stimulation by combining LED and laser technology to target hair follicles and promote cellular activity in the scalp. It is intended for use exclusively in clinical settings under professional supervision, not for home use.
Is the Nooance LED and Laser Helmet a single-use or reusable device?
The Nooance LED and Laser Helmet is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical environments after proper cleaning and maintenance.
Does the Nooance LED and Laser Helmet come with any specific sterility guarantees or instructions?
The provided data does not specify any sterility guarantees or instructions for the Nooance LED and Laser Helmet. Users should follow standard clinical protocols for cleaning and disinfection to ensure safe reuse.
What regulatory pathway was followed for the FDA clearance of the Nooance LED and Laser Helmet?
The Nooance LED and Laser Helmet received FDA clearance through a 510(k) submission (K231321) under the Traditional clearance type, determined to be Substantially Equivalent to a predicate device. The submission was reviewed by the Physical Medicine (PM) advisory committee and falls under the product code OAP, with regulatory classification under 21 CFR 890.5500.
Are there multiple models or sizes available for the Nooance LED and Laser Helmet?
The data lists multiple FEI numbers (e.g., 3013503862, 3015287734, etc.), which may correspond to different models or configurations of the helmet. However, specific details about variations in size, wavelength, or other technical specifications are not provided in the summary. Contacting the manufacturer would be necessary for precise model or size information.
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. Sources consulted: Light Therapy Mask Manufacturer | Kymedical, K231321 FDA 510 (k) - Nooance Led And Laser Helmet, Nooance Led And Laser Helmet (K231321) — FDA 510(k) | Innolitics, Kaiyan Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231321 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Kaiyan Medical Equipment Co, . Ltd
- FDA Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
Sources (1)
- FDA 510(k) K231321 24 fields · synced Oct 6, 2026