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Apira Science, Inc.

4 FDA records filed under this company name, from 2012 to 2024, in hair growth (OAP, 4).

The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.

Laser and LED hair-growth caps, helmets and combs (1 record says prescription use) (OAP, 4)

510(k) cleared

GroWell BT Hair Growth System (GW10042)

510(k) number
K242619
Applicant
Apira Science, Inc.
Product code
OAP: Laser, Comb, Hair
Regulation
21 CFR 890.5500, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

IGROW II HAIR GROWTH SYSTEM

510(k) number
K140931
Applicant
Apira Science, Inc.
Product code
OAP: Laser, Comb, Hair
Regulation
21 CFR 890.5500, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The igrow-II Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM

510(k) number
K141567
Applicant
Apira Science, Inc.
Product code
OAP: Laser, Comb, Hair
Regulation
21 CFR 890.5500, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

IGROW II HAIR GROWTH SYSTEM

510(k) number
K122248
Applicant
Apira Science, Inc.
Product code
OAP: Laser, Comb, Hair
Regulation
21 CFR 890.5500, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 7.