GroWell BT Hair Growth System (GW10042)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242619 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 GroWell BT Hair Growth System (GW10042) is a low-level laser therapy device classified as a laser comb for hair growth. It delivers targeted laser energy to stimulate hair follicles, promoting hair regrowth in individuals with genetic hair loss. Designed as a non-invasive, non-surgical treatment, it operates within the physical medicine category and is intended for use on the scalp to encourage natural hair growth.
The device is supplied as a reusable, non-sterile system intended for home use. It requires no special storage conditions and is not intended for use in MRI environments. The system is cleared by the FDA under the 510(k) pathway as substantially equivalent to predicate devices, with a classification of Class II. No additional regulatory markings or certifications are specified beyond the FDA clearance.
Frequently asked questions
What is the primary purpose of the GroWell BT Hair Growth System (GW10042) and how does it work?
The GroWell BT Hair Growth System (GW10042) is designed as a low-level laser therapy device in the form of a laser comb. It delivers targeted laser energy to the scalp to stimulate hair follicles, aiming to promote natural hair regrowth in individuals experiencing genetic hair loss. It operates as a non-invasive, non-surgical treatment, using physical medicine principles to encourage follicle activity without surgery or invasive procedures.
Is the GroWell BT Hair Growth System intended for professional use in clinics, or is it meant for home use?
The device is explicitly supplied as a reusable system intended for home use, meaning it is not designed for clinical or professional settings. It is meant to be used by individuals in their own homes to address hair loss.
Does the GroWell BT Hair Growth System require any special storage conditions, and can it be used in an MRI environment?
The system does not require special storage conditions, such as refrigeration or humidity control, and can be stored under normal household conditions. However, it is not intended for use in MRI environments, as laser devices may interfere with magnetic resonance imaging.
How is the regulatory status of the GroWell BT Hair Growth System determined, and what classification does it hold?
The device was cleared by the FDA under the 510(k) pathway, with a determination of substantial equivalence (SE) to predicate devices. It is classified as Class II, which is typical for devices requiring special controls to ensure safety and effectiveness, such as laser combs for hair growth.
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: GroWell Hair Regrowth Cap - Apira Science, Inc., Apira Science GW10042 Hair Growth Laser Hat User Manual, PDF Apira Science GW10042 Hair Growth Laser Hat User Manual, K242619 FDA 510(k) - GroWell BT Hair Growth System (GW10042)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242619 | Class II | Active |
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Manufacturer
- Manufacturer
- Apira Science, Inc.
Sources (1)
- FDA 510(k) K242619 24 fields · synced Sep 20, 2026