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The HairMax Laser 272, 202 and 80 are indicated to promote hair growth in males with androgentic alopecia who have Norwood-Hamilton Classifications of IIa - V, or females with androgenetic alopecia who have Ludwig-Savin Classifications I - II or Frontal and for both with Fitzpatrick Skin Phototypes I- IV.

The HairMax Laser 272, 202 or 80 each contain the listed number of diode lasers configured within an outer cap helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head i.e., the area commonly covered with stylized hair. The HairMax Laser 272, 202 and 80 are powered by a lithium-ion battery pack that contains an embedded controller chip. In all other area of design, manufacturing, and aesthetic appearance, the devices are identical.

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.

The HairMax LaserComb 41 (HMLC 41) and HairMax LaserComb 82 (HMLC 82) are low-level laser devices that provide distributed laser light to the scalp while comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The HMLC 82 device emits 82 laser beams with wavelengths of 655 nm (+/- 10 nm), spaced at 7mm intervals and has a total laser module output within the limitation of a Class 3R laser. The HMLC 41 device emits 41 laser beams with wavelengths of 655 mm (+/- 10 nm), spaced at 7mm intervals and has a total laser module output within the limitation of a Class 3R laser. The laser diode modules used in the HMLC 41 & 82 are identical to those used in their predicate devices. As with the predicate device, the HMLC 41 & 82's lasers are contained in between hair parting teeth that push the hair aside, allowing the optimum amount of laser energy to reach the scalp, as the user passes over the scalp. The hair parting teeth move the hair aside and allow an unobstructed path of laser energy to the scalp. At the beginning of a treatment session, the device is placed in the first position on the scalp (the first 7.5cm scalp section, closest to the forehead) and will rest here for the intended treatment time. As with the predicate devices, the HMLC 41 & 82 will use a short vibration to advise the user it is time to move to the next scalp location. The HMLC 41 & 82 will maintain contact with the scalp allowing the hair parting teeth to part the hair as the user moves the device backwards, combing the hair, along the scalp to the second position. The teeth are necessary to part the hair and provide an unobstructed path for the laser light to reach the scalp. The device will remain in the second position until the vibration informs the user to move to the third position. Similar indication and movement will continue for three positions to cover the entire area of hair loss on the scalp. The lasers will automatically turn off after the intended treatment duration. The units operate from an internal, rechargeable lithium polymer battery. The LiPoly battery is charged from a Class 2, UL, and CUL rated wall transformer at 6VDC and 1000mA. In the event of a power failure, the laser control circuitry is designed to disable the laser diodes until reactivated by the control switch. The devices include battery monitoring and charging circuitry which ensure the effective delivery of optimal laser energy output during the treatment time. The devices include a proximity sensor and will not allow the lasers to be turned on unless in contact with the scalp.

The HairMax LaserComb Advanced 7 is indicated to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I to IV. The HairMax LaserComb Pro 12 is indicated to treat Androgenetic Alopecia and promote hair growth in females with who have Ludwig-Savin Scale 1-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I to IV.

Similar to the HairMax Lux 9 K110233, the modified HairMax Advanced 7 and Pro 12 consist of a hand-held low level laser device that emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp.

The HairMax Dual 12 is indicated to Treat Androgenetic Alopecia and Promote Hair Growth in Females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal and Fitzpatrick Skin Types I to IV.

Substantially equivalent to the HairMax Pro 12 (K103368) and HairMax Lux 9 for females (K110233), the HairMax Dual 12 is a hand-held low-level laser device that emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure maximum laser light reaches the user's scalp. HairMax Dual 12 utilizes twelve laser modules, six with wavelengths of 655nm and six with wavelengths of 635nm with the same exact output power as the HairMax Pro 12.

The HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 are indicated to treat androgenetic alopecia, promote hair growth and help prevent further hair loss in males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss and Fitzpatrick Skin Types I to IV.

Substantially equivalent to the HairMax LaserComb (K060305, K093499), the modified HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 are handheld low level laser devices that emits laser light with the intention to promote hair growth. The devices provide distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 replace the cleared version's single beam laser and beam splitting reflector with a circuit board containing seven, nine, or twelve laser diodes. respectively.

The HairMax LaserComb is indicated to promote hair growth in males, 30-60 years of age with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and Fitzpatrick Skin Types I to IV.

Similar to the HairMax LaserComb K060305, the modified HairMax LaserComb consists of a hand-held low level laser device that emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The predicate unit operates from solely on a class 2, UL and CUL rated wall transformer. The modified unit adds a Lithium ion battery power supply option. In addition, cosmetic changes are being made to the device color and exterior plastic housing. Changes do not alter form fit or function as compared to the predicate device.

The LaserComb is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV.

The LaserComb consists of a hand-held low level laser device that promotes hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. When in use, the device emits a beep every four seconds to notify the user to move the device to a new section of the scalp.