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Lexington International, LLC

8 FDA records filed under this company name, from 2007 to 2018, in hair growth (OAP, 8).

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, 8)

510(k) cleared

HairMax Laser

510(k) number
K180885
Applicant
Lexington International, LLC
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 HairMax Laser 272, 202 and 80 are indicated to promote hair growth in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa – V, females who have Ludwig-Savin Classifications of I – II or Frontal 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

HairMax LaserComb, HairMax LaserComb

510(k) number
K142573
Applicant
Lexington International, LLC
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 HairMax LaserComb 41 is indicated to treat Androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, …”

Read the full statement

“The HairMax LaserComb 41 is indicated to treat Androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV. The HairMax LaserComb 82 is indicated to treat Androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.”

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

510(k) cleared

HAIRMAX LASERCOMB

510(k) number
K112524
Applicant
Lexington International, LLC
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 1.

510(k) cleared

HAIRMAX DUAL 12

510(k) number
K111714
Applicant
Lexington International, LLC
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 2.

510(k) cleared

HAIRMAX LASERCOMB

510(k) number
K110233
Applicant
Lexington International, LLC
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. FDA doesn't host a document for this record at the usual address.

510(k) cleared

HAIRMAX LASERCOMB

510(k) number
K103368
Applicant
Lexington International, LLC
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. FDA's PDF for this record is a scanned image with no text, so we can't quote it. Read FDA's PDF.

510(k) cleared

HAIRMAX LASERCOMB

510(k) number
K093499
Applicant
Lexington International, LLC
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 2.

510(k) cleared

HAIRMAX LASERCOMB

510(k) number
K060305
Applicant
Lexington International, LLC
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 2.