# K150613: LaserCap LC Pro and LC Elite

- Pathway: 510(k) (Traditional)
- Applicant: Transdermal Cap, Inc.
- Decided: Jul 22, 2015 after 134 days
- Product code: OAP (Laser, Comb, Hair)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001179 (2000). 8 ancestors in all.
46 later devices descend from it; 4 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143199: Capillus 272 Pro, Capillus, LLC (2015) Summary page 4.
- K113097: Laser Helmet, Theradome, Inc. (2012) Summary page 4.

## Most influential descendants
- K153618: Capillus202 (2016), 44 descendants of its own
- K162782: iHelmet Hair Growth System (2017), 22 descendants of its own
- K161875: LaserCap300, LaserCap224, LaserCap120, LaserCap80 (2016), 20 descendants of its own
- K173729: Revian Red (2018), 19 descendants of its own
- K211038: Biophotas Celluma RESTORE (2021), 9 descendants of its own

## Indications for 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.

Source page: https://510kreport.com/device/K150613
Methodology: https://510kreport.com/methodology