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Hair Growth Device - KCA441-88S

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250308

by Dongguan Boyuan Intelligent Technology Co., Ltd

Identifiers

510(k) Number
K250308 FDA 510(k)
FDA Product Code
OAP FDA 510(k)
Models / Variants
KCA441-200 FDA 510(k)
KCA441-120 FDA 510(k)
KCA441-88 FDA 510(k)
KCA441-56 FDA 510(k)
KCA441-200S FDA 510(k)
KCA441-120S FDA 510(k)
KCA441-88S FDA 510(k)
KCA441-56S FDA 510(k)
KCA451-200 FDA 510(k)
KCA451-120 FDA 510(k)
KCA451-88 FDA 510(k)
KCA451-56 FDA 510(k)
KCA451-200S FDA 510(k)
KCA451-120S FDA 510(k)
KCA451-88S FDA 510(k)
KCA451-56S 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 Hair Growth Device is a laser comb designed for hair growth applications. It functions as a physical medicine device classified under regulation number 890.5500.

This device is manufactured by Dongguan Boyuan Intelligent Technology Co., Ltd. and has received FDA 510(k) clearance. It is available in multiple model configurations, including KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, and KCA451-56S.

Frequently asked questions

What is the primary purpose of the Hair Growth Device?

The Hair Growth Device is a laser comb intended for hair growth applications. It is classified as a physical medicine device under regulation number 890.5500.

What model configurations are available for this device?

This device is available in a wide range of model configurations, including the KCA441 series (KCA441-200, KCA441-120, KCA441-88, KCA441-56, and their 'S' variants) and the KCA451 series (KCA451-200, KCA451-120, KCA451-88, KCA451-56, and their 'S' variants).

What is the regulatory status of this device?

The Hair Growth Device has received FDA 510(k) clearance, as indicated by its regulatory filing under K-number K250308.

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: Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56 ..., K250308 - Hair Growth Device (KCA441-200, KCA441-120, KC..., Hair Growth Device (KCA441-200, KCA441-120… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dongguan Boyuan Intelligent Technology Co., Ltd
FDA Applicant
Dongguan Boyuan Intelligent Technology Co.,Ltd

Sources (1)

  • FDA 510(k) K250308 24 fields · synced Oct 6, 2026