510(k) K242619

Device
GroWell BT Hair Growth System (GW10042)
Applicant
Apira Science, Inc.
510(k) number
K242619
Product code
OAP
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-02
Date received
2024-09-03
Regulation
890.5500
Classification name
Laser, Comb, Hair
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Ray Pizinger
Address
409 Edmon Rd. NE Suite C Albuquerque NM US 87107 87107

FDA Registration Numbers

Source Documents

510(k) summary PDF

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