Capillus, LLC

7 FDA records filed under this company name, from 2015 to 2017, in hair growth (OAP, 7).

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, 7)

510(k) clearedJan 31, 2017

Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352

510(k) number: K163170
Applicant: Capillus, LLC
Product code: OAP: Laser, Comb, Hair
Regulation: 21 CFR 890.5500, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Nov 14, 2016

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.

FDA database record FDA document (PDF)

510(k) clearedNov 18, 2016

Capillus302, Capillus312, Capillus352

510(k) number: K162994
Applicant: Capillus, LLC
Product code: OAP: Laser, Comb, Hair
Regulation: 21 CFR 890.5500, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Oct 27, 2016

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.

FDA database record FDA document (PDF)

510(k) clearedApr 25, 2016

Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202

510(k) number: K160285
Applicant: Capillus, LLC
Product code: OAP: Laser, Comb, Hair
Regulation: 21 CFR 890.5500, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Feb 3, 2016

Indications for use, as filed

“The Capillus272 Pro, Capillus272 OfficePro, Capillus82, and Capillus202 are intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I- II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V ; and both genders having 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.

FDA database record FDA document (PDF)

510(k) clearedJan 19, 2016

Capillus202

510(k) number: K153618
Applicant: Capillus, LLC
Product code: OAP: Laser, Comb, Hair
Regulation: 21 CFR 890.5500, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Dec 18, 2015

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.

FDA database record FDA document (PDF)

510(k) clearedAug 21, 2015

Capillus82

510(k) number: K151516
Applicant: Capillus, LLC
Product code: OAP: Laser, Comb, Hair
Regulation: 21 CFR 890.5500, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Jun 5, 2015

Indications for use, as filed

“The Capillus82 is indicated to promote hair growth in females who have androgenic alopecia and Ludwig-Savin Classifications of I- II; and with 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.

FDA database record FDA document (PDF)

510(k) clearedJun 9, 2015

Capillus 272 Office Pro

510(k) number: K150578
Applicant: Capillus, LLC
Product code: OAP: Laser, Comb, Hair
Regulation: 21 CFR 890.5500, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Mar 9, 2015

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.

FDA database record FDA document (PDF)

510(k) clearedJan 29, 2015

Capillus 272 Pro

510(k) number: K143199
Applicant: Capillus, LLC
Product code: OAP: Laser, Comb, Hair
Regulation: 21 CFR 890.5500, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Nov 6, 2014

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.

FDA database record FDA document (PDF)