# K111286: Quasar Calypso

- Pathway: 510(k) (Traditional)
- Applicant: Silver Bay, LLC
- Decided: Jan 18, 2012 after 257 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: 12 generations back to K943450 (1995). 136 ancestors in all.
76 later devices descend from it; 1 cites it directly.
0 of 213 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093963: Quasar Blue Light Therapy System, Silver Bay, LLC (2010) Summary page 2.
- K060792: Illumimed, Photoactif, LLC (2006) Summary page 2.
- K083183: Aklarus Phototherapy System, Hill Laboratories Co. (2009) Summary page 2.
- K081307: Omnilux Clear-U, Photo Therapeutics, Inc. (2009) Summary page 2.

## Most influential descendants
- K162098: LED Phototherapy Device (2017), 75 descendants of its own
- K171821: 2 Face / Face Evolution (2018), 58 descendants of its own
- K192295: PDT-Face (2020), 46 descendants of its own
- K212155: TheraFace LED (2021), 42 descendants of its own
- K223544: LED light therapy mask (FM-01, FM-02, FM-03) (2023), 39 descendants of its own

## Indications for use
The Quasar Calypso C50 is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.

Source page: https://510kreport.com/device/K111286
Methodology: https://510kreport.com/methodology