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Transdermal Cap, Inc.

3 FDA records filed under this company name, from 2015 to 2021, in hair growth (OAP, 3).

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, 3)

510(k) cleared

LaserCap Family of Lasers 300, 224, 120 & 80

510(k) number
K203826
Applicant
Transdermal Cap, 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 LaserCap Family of Lasers, models 300, 224, 120 and 80 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I – II, and males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Skin Phototypes I to IV.”

Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.

510(k) cleared

LaserCap300, LaserCap224, LaserCap120, LaserCap80

510(k) number
K161875
Applicant
Transdermal Cap, 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 statement's clinical classification text (such as Norwood-Hamilton or Ludwig-Savin ranges) doesn't read cleanly, so we don't quote it rather than guess at a correction. Read FDA's PDF, page 4.

510(k) cleared

LaserCap LC Pro and LC Elite

510(k) number
K150613
Applicant
Transdermal Cap, 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 LC PRO and LC ELITE are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of I-IV.”

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