Laser Hair Growth Device
by Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd.
510(k) K210169
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210169 | Date16 Apr 2021 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Hair Growth Device
- 510(k) Number
- FDA Product Code
- OAP
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5500
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a laser comb for hair growth, classified under Physical Medicine, designed to stimulate hair regrowth through low-level laser therapy. It operates by emitting specific wavelengths of light to target hair follicles, aiming to promote cellular activity and improve hair density in affected areas.
The device is supplied as a reusable, non-sterile electrical appliance intended for at-home use. It is cleared under the FDA’s 510(k) pathway (K210169) as Substantially Equivalent to a predicate device, with no explicit MRI safety restrictions noted. Sizes or configurations are not specified in the regulatory data, and no additional storage or handling instructions are provided beyond standard electrical appliance guidelines.
Questions
AI-generated answers, 19 Sep 2026
How does this laser comb work to promote hair growth, and is it designed for professional or at-home use?
This device uses low-level laser therapy to stimulate hair follicles by emitting specific wavelengths of light, which aims to enhance cellular activity and improve hair density in targeted areas. It is explicitly designed for at-home use as a reusable, non-sterile electrical appliance, making it accessible for personal application without requiring clinical or professional settings.
Is this device single-use or reusable, and what are the basic maintenance requirements?
The device is reusable and not intended for single-use. Since it is non-sterile, standard electrical appliance guidelines apply for maintenance, though no specific storage or handling instructions beyond general care are provided in the regulatory data. Users should follow basic electrical safety practices, such as unplugging when not in use and avoiding exposure to moisture.
Are there different sizes or configurations available for this laser comb, and how would I know which one to choose?
The regulatory data does not specify sizes or configurations for this device, meaning all versions appear to be standardized. Since no variations are mentioned, selection would depend on general fit and comfort for the user’s head size, but no technical or model-specific guidance is provided to differentiate between options.
What regulatory pathway was used to clear this device, and is it safe to use near MRI machines?
This device was cleared under the FDA’s 510(k) pathway (K210169), determined to be *Substantially Equivalent* to a predicate device in the category of Physical Medicine. While no explicit MRI safety restrictions are noted in the data, users should consult the manufacturer’s instructions or a radiologist before using it near MRI environments to ensure compatibility and safety.
Who should I contact if I need technical support or additional information about this device?
For technical support or further details, you may reach out to the manufacturer, Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd., via their listed contact, Liu Jianwen. The address provided is 401, Bldg. 1, #3, Xinxing 3rd Rd., Jiaoshe, Dongkeng, Dongguan, 523586, China, though direct contact methods (e.g., phone/email) are not specified in the regulatory data.