# K152889: Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean Plus

- Pathway: 510(k) (Traditional)
- Applicant: Biorenew Labs, LLC
- Decided: Dec 30, 2015 after 91 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.
3 later devices descend from it; 1 cites it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121435: Silkn Blue, Home Skinovations, Ltd. (2013) Summary page 6.
- K124042: Tanda Mini Skincare System, Syneron Beauty (2013) Summary page 6.

## Most influential descendants
- K170260: BC-001+ Acne Purifier (2017), 2 descendants of its own
- K220729: The Luminance RED Acne Device (2022), 1 descendant of its own
- K251843: Erchonia EVRL (2025), 0 descendants of its own

## Indications for use
The Sonilase Blue is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in the treatment of mild to moderate acne vulgaris. The Sonilase Blue-UV Clean is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in the treatment of mild to moderate acne vulgaris. The Sonilase Blue-UV Clean Plus is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in the treatment of mild to moderate acne vulgaris.

Source page: https://510kreport.com/device/K152889
Methodology: https://510kreport.com/methodology