Laser Cap Hat-01

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Laser Cap, Model: Hat-01

510(k) Number

K232356 ↗

FDA Product Code

OAP

FDA applicant

Hubei Yjt Technology Co.,Ltd

Device Class

Class II

Regulation

21 CFR Part 890.5500

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Laser Hair Growth System (Laser Cap 128)

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  FDA 510(k) K253231 Active Cleared 16 Jun 2026

• Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002

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  FDA 510(k) K230134 Active Cleared 23 May 2023

• What is the primary purpose of the Laser Cap, Model Hat-01, and how does it work?

  The Laser Cap, Model Hat-01, is designed for hair regrowth therapy using low-level laser therapy (LLLT). It employs 82 diode lasers to deliver targeted light energy to the scalp, aiming to stimulate dormant hair follicles and promote increased hair density. This device is intended for use in both clinical and home settings.

• Is the Laser Cap, Model Hat-01, reusable or single-use, and how should it be stored?

  The Laser Cap, Model Hat-01, can be supplied as either single-use or reusable, depending on the manufacturer’s specifications. Proper storage and handling are required as outlined in the device’s instructions for use to ensure optimal performance and safety.

• What regulatory pathway was followed for the FDA clearance of the Laser Cap, Model Hat-01?

  The Laser Cap, Model Hat-01, received FDA clearance through a traditional 510(k) pathway (K232356), with a decision classification of substantially equivalent under the Physical Medicine advisory committee. The device is classified as a Class II medical device.

• Can the Laser Cap, Model Hat-01, be used in an MRI environment, and what is its compatibility status?

  The Laser Cap, Model Hat-01, is explicitly stated to operate without MRI compatibility concerns, meaning it is safe for use in non-MRI environments but should not be used inside an MRI scanner.