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510(k) Data Aggregation
K Number
K203826Device Name
LaserCap Family of Lasers 300, 224, 120 & 80
Manufacturer
Transdermal Cap, Inc.
Date Cleared
2021-03-29
(90 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Transdermal Cap, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Promoting hair growth in females with Androgenetic Alopecia who have Ludwig -Savin Classifications of I-II and males who have Norwood-Hamilton Classifications of Ila - V and for both, Fitzpatrick Classifications of Skin Phototypes of I-IV.
Device Description
The LaserCap Family of Lasers, models 300, 224, 120 and 80 contains 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 LaserCap models are powered by a lithium-ion battery pack that contains an embedded controller chip.
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K Number
K161875Device Name
LaserCap300, LaserCap224, LaserCap120, LaserCap80
Manufacturer
TRANSDERMAL CAP, INC.
Date Cleared
2016-09-30
(84 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
TRANSDERMAL CAP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LaserCap300, LaserCap224, LaserCap120, and LaserCap80 are intended for the promotion of hair growth in females with androgenetic alopeda who have Ludwig-Savin Classifications of 1 - 11 and males with androgenetic alopecia who have Hamilton-Norwood Classifications of lla-V and for both, Fitzpatrick Skin Phototypes I to IV.
Device Description
LaserCap300, LaserCap224, LaserCap120, and LaserCap80 consist of 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. The devices only vary in number of lasers (300, 224, 120, and 80 diodes, respectively) and LaserCap300 has a small extension of the LaserCap housing perimeter where its additional laser diodes target peripheral hair-bearing areas of the scalp. 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 (1 short beep) or ended (one long beep). The portable systems are powered by rechargeable Li-lon battery cells assembled into a proprietary battery pack. Both the battery pack and charger are fully compliant to recognized, international standards.
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K Number
K150613Device Name
LaserCap LC Pro and LC Elite
Manufacturer
TRANSDERMAL CAP, INC.
Date Cleared
2015-07-22
(134 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
TRANSDERMAL CAP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The LCPro consists of 224 red, visible-light, pulsed-emission diode lasers operating at 650 nanometers, that are configured within a protective inner liner and outer helmet. The LCElite is physically similar to the LCPro, except that it is configured with 80 red, visible-light, continuous-emission diode lasers, also operating at 650 nanometers and also configured within a protective inner liner and outer helmet. The use of these 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 reestablished. 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 Lithium Ion battery cells assembled into a proprietary battery pack. Both the battery cells pack and charger are fully compliant to recognized, international standards.
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