# K091467: Baby Quasar

- Pathway: 510(k) (Traditional)
- Applicant: Silver Bay, LLC
- Decided: Sep 17, 2010 after 487 days
- Product code: ONE (Powered Light Based Non-Laser Surgical Instrument)
- 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). 91 ancestors in all.
No later device cites it as a predicate yet.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072459: Omnilux New-U, Photo Therapeutics, Inc. (2008) Summary page 1.

## Indications for use
This is a hand held device intended to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Source page: https://510kreport.com/device/K091467
Methodology: https://510kreport.com/methodology