K242619
- 510(k) number
- K242619
- Device name
- GroWell BT Hair Growth System (GW10042)
- Applicant
- Apira Science, Inc. NM · US
- Product code
- OAP — Laser, Comb, Hair
- Decision date
- 2024-12-02
- Date received
- 2024-09-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K242619.pdf
Official FDA record: K242619
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.