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Capillus302, Capillus312, Capillus352 Laser Comb

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162994

by Capillus, LLC

Identifiers

510(k) Number
K162994 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 Capillus302, Capillus312, and Capillus352 are low-level laser therapy devices designed for hair growth promotion. Each model incorporates 302, 312, or 352 red diode lasers (650 nm) integrated into a helmet with an inner protective liner, delivering targeted light therapy to the scalp.

These devices are portable, powered by rechargeable batteries, and intended for at-home use. They are classified as Class II medical devices under FDA regulations (K162994, OAP product code) and are not sterile or single-use. No specific MRI safety or sterilization requirements are noted in the data.

Frequently asked questions

What are the key differences between the Capillus302, Capillus312, and Capillus352 models in terms of their design and functionality?

The Capillus302, Capillus312, and Capillus352 differ primarily by the number of red diode lasers integrated into their helmets: the 302 model has 302 lasers, the 312 has 312, and the 352 has 352. All three deliver low-level laser therapy (650 nm wavelength) for hair growth promotion, with the higher-numbered models offering slightly more coverage or intensity. They are all portable, battery-powered, and designed for at-home use.

Are these devices reusable or single-use, and what maintenance is required?

The Capillus302, Capillus312, and Capillus352 are not single-use—they are reusable devices intended for long-term at-home use. Since they are not sterile, they do not require sterilization between uses. However, the manufacturer likely provides guidelines for cleaning the helmet’s protective liner and battery maintenance, as they are powered by rechargeable batteries.

How should these devices be stored when not in use?

While the data does not specify exact storage instructions, as portable, battery-powered devices, they should ideally be stored in a cool, dry place away from direct sunlight or extreme temperatures. The rechargeable battery should be fully charged periodically to prevent degradation, and the helmet should be kept clean and free from dust or moisture to maintain functionality.

What regulatory pathway was followed for FDA clearance of these devices?

The Capillus302, Capillus312, and Capillus352 were cleared through the FDA’s 510(k) pathway under Special 510(k) review, classified as Class II medical devices under the Physical Medicine advisory committee. The clearance (K162994) was granted on November 18, 2016, with a decision of Substantially Equivalent (SESE) to a predicate device. The product code assigned is OAP, indicating they are intended for hair growth promotion via low-level laser therapy.

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: Capillus302, Capillus312, Capillus352 (K162994) — FDA 510(k ..., PDF K162994.510kSummary.FINAL, CapillusRX™ Laser Cap - Shop Diamond Face Institute

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Capillus, LLC

Sources (1)

  • FDA 510(k) K162994 24 fields · synced Sep 19, 2026