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The Capillus laser domes 82, 202, 272 Pro, 272 OfficePro, 302, 312, and 352, are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.

The Capillus272 Pro and Capillus272 OfficePro both consist of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner, and configured for portable use with rechargeable battery and adapter (Capillus272 Pro) and salon/spa use (Capillus272 OfficePro). The Capillus82, Capillus202, Capillus302, Capillus312, and Capillus352 are exactly the same as the Capillus272 Pro with the exception of the number of diodes which are respective of model (e.g. 82 diodes in Capillus82). As stated in prior submissions, the devices emit an audible tone at the beginning and end of a therapy session, indicating that therapy has begun (2 short beeps) or ended (one long beep). The portable systems are powered by rechargeable Li-Ion battery cells assembled into a proprietary battery pack. Both the battery are fully compliant to recognized, international standards. The OfficePro is directly powered by the DC charger, which is fully compliant to recognized, international standards.

The Capillus302, Capillus312, and Capillus352, are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.

The Capillus302, Capillus312, and Capillus352 consist of 302, 312, or 352 (respectively) red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable use with rechargeable battery and adapter. These models are exactly the same as the (predicate) Capillus family of devices (Capillus272, Capillus202, Capillus82) with the exception of the number of diodes. As stated in prior submissions, the devices emit an audible tone at the beginning and end of a therapy session, indicating that therapy has begun (2 short beeps) or ended (one long beep). The portable systems are powered by rechargeable Li-Ion battery cells assembled into a proprietary battery pack. Both the battery are fully compliant to recognized, international standards.

The Capillus272 Pro, Capillus82 OfficePro, 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.

The Capillus272 Pro and Capillus272 OfficePro both consist of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner, and configured for portable use with rechargeable battery and adapter (capillus272 Pro) and clinical office use (Capillus272 OfficePro). The Capillus82 and Capillus202 are exactly the same as the Capillus272 Pro with the exception of the number of diodes which are 82 and 202 respectively. As stated in prior submissions, the devices emit an audible tone at the beginning and end of a therapy session, indicating that therapy has begun (2 short beeps) or ended (one long beep). The portable systems are powered by rechargeable Li-Ion battery cells assembled into a proprietary battery pack. Both the battery are fully compliant to recognized, international standards. The OfficePro is directly powered by the DC charger, which is fully compliant to recognized, international standards.

The Capillus202 is indicated to promote hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications of I-II, and with Fitzpatrick Skin Phototypes I-IV.

The Capillus202 consists of 202 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable use with rechargeable battery and adapter. Just as for the previous version, the helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. This is achieved by a safety interlock. At the beginning and of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by rechargeable Nickel Metal Hydride battery cells assembled into a proprietary battery pack. Both the battery pack and charger are fully compliant to recognized, international standards.

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.

The Capillus82 consists of 82 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable use with rechargeable battery and adapter.

Promote hair growth in females diagnosed with androgenetic alopedia presenting with Ludwig-Savin Classifications I-II and Fitzpatrick Skin Phototypes I-IV.

The Capillus272 OfficePro is exactly the same as the Capillus272 Pro in every way except the following: - 1. The Capillus272 OfficePro is the same hat, but mounted on a stand. The same electrical design has been applied (i.e. adapter steps down to ~12V DC; but no battery as it is not intended to be portable). The Capillus272 Pro consists of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable battery and adapter. The Capillus272 OfficePro is intended for in-office use and is not intended to be portable. The same hat is mounted on a stand and the adapter is connected directly to the cap through wiring threaded through the stand. Just as for the previous version, the helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. This is achieved by a safety interlock. At the beginning and end of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by rechargeable Nickel Metal Hydride battery cells (Capillus272 Pro only) assembled into a proprietary pack. Both the battery pack and charger are fully compliant to recognized, international standards.

The Capillus272 Pro is 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

The Capillus272Pro consists of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner. The use of this specific number 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 helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. This is achieved by a safety interlock. At the beginning and end of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by rechargeable Nickel Metal Hydride battery cells assembled into a proprietary battery pack. Both the battery cells, pack and charger are fully compliant to recognized, international standards.