# K153081: Clear Bi-Light

- Pathway: 510(k) (Traditional)
- Applicant: Michael Todd, LP
- Decided: Feb 15, 2016 after 115 days
- Product code: OLP (Over-The-Counter Powered Light Based Laser For Acne)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K943450 (1995). 98 ancestors in all.
46 later devices descend from it; 3 cite it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124042: Tanda Mini Skincare System, Syneron Beauty (2013) Summary page 4.
- K121435: Silkn Blue, Home Skinovations, Ltd. (2013) Summary page 4.
- K081307: Omnilux Clear-U, Photo Therapeutics, Inc. (2009) Summary page 4.

## Most influential descendants
- K180447: reVive Light Therapy LED Cleansing System (2018), 35 descendants of its own
- K180900: LED Light Therapy Device (2018), 29 descendants of its own
- K183708: Poly Clear (2019), 22 descendants of its own
- K183118: dpl SpotLite (2019), 22 descendants of its own
- K203214: DemarkQ WOW, DemarkQ POP (2021), 21 descendants of its own

## Indications for use
The Clear Bi-Light is indicated for the treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K153081
Methodology: https://510kreport.com/methodology