Identifiers
- 510(k) Number
- K111714 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 HairMax Dual 12 is a Laser Comb for Hair, designed to stimulate hair growth through low-level laser therapy (LLLT). It delivers targeted laser energy to the scalp to promote hair density and thickness in individuals experiencing hair loss or thinning. The device operates within the physical medicine category, utilizing a combination of 12 low-power lasers arranged in a comb-like configuration for application across the scalp.
The HairMax Dual 12 is supplied as a reusable, non-sterile medical device intended for home use. It is classified as a Class II device under FDA regulation 890.5500 and received FDA 510(k) clearance (K111714) for substantial equivalence. The device requires no special storage conditions beyond a clean, dry environment and is not intended for use in MRI settings. No additional regulatory authorisations beyond the 510(k) clearance are stated.
Frequently asked questions
What is the HairMax Dual 12 Laser Comb used for?
The HairMax Dual 12 Laser Comb is designed to stimulate hair growth through low-level laser therapy (LLLT). It delivers targeted laser energy to the scalp to help promote hair density and thickness in individuals experiencing hair loss or thinning. This device falls under the category of physical medicine and is intended for home use.
Is the HairMax Dual 12 Laser Comb reusable or single-use?
The HairMax Dual 12 Laser Comb is a reusable device. It is not intended for single-use and is meant to be used repeatedly by individuals at home to maintain hair health.
What are the storage requirements for the HairMax Dual 12 Laser Comb?
The HairMax Dual 12 Laser Comb requires no special storage conditions beyond keeping it in a clean, dry environment. It is not intended for use in MRI settings, so it should be stored away from such environments to avoid potential interference.
Is the HairMax Dual 12 Laser Comb sterile?
No, the HairMax Dual 12 Laser Comb is classified as a non-sterile medical device. It is intended for home use and does not require sterile conditions for operation.
What regulatory approval does the HairMax Dual 12 Laser Comb have?
The HairMax Dual 12 Laser Comb has received FDA 510(k) clearance (K111714) for substantial equivalence under the classification of Class II device (regulation number 890.5500). This clearance indicates that the device meets FDA standards for safety and effectiveness in its intended 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. Sources consulted: PDF Lexington, HAIRMAX DUAL 12 (K111714) — FDA 510 (k) | Innolitics, HAIRMAX DUAL 12 510 (k) K111714 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111714 | Class II | Active |
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Manufacturer
- Manufacturer
- Lexington International, LLC
Sources (1)
- FDA 510(k) K111714 24 fields · synced Oct 1, 2026