# K093963: Quasar Blue Light Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Silver Bay, LLC
- Decided: Aug 27, 2010 after 247 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: 1 generation back to K072767 (2007). 1 ancestor in all.
130 later devices descend from it; 4 cite it directly.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072767: Quasar Blue Light Therapy System, Silver Bay, LLC (2007) Summary page 1.

## Most influential descendants
- K121435: Silkn Blue (2013), 125 descendants of its own
- K131461: Lightstim for Acne/ Lightstim for Acne Mini (2014), 81 descendants of its own
- K111286: Quasar Calypso (2012), 76 descendants of its own
- K162098: LED Phototherapy Device (2017), 75 descendants of its own
- K171821: 2 Face / Face Evolution (2018), 58 descendants of its own

## Indications for use
The "Quasar Blue" Blue Light Therapy System is intended to provide photo therapeutic light to the body. The 'Quasar Blue" Blue Light Therapy System is generally indicated to treat dermatological conditions. The 'Quasar Blue" Blue Light Therapy System is specifically indicated to emit visible blue/violet light to treat mild to moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K093963
Methodology: https://510kreport.com/methodology