# K073477: Photonova Family of Pulsed Light Systems

- Pathway: 510(k) (Traditional)
- Applicant: Photonova Ofsweden AB
- Decided: May 9, 2008 after 150 days
- Product code: GEX (Powered 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: 7 generations back to K910422 (1992). 25 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032191: Omnilight Fluorescent Pulsed Light System, Luxsano AB (2003) Summary page 1.
- K040081: Palomar Luxv Handpiece, Palomar Medical Technologies, Inc. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K033349: AC-1 SP02 Adaptor Cable, Model AC-1, Masimo Corp. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K092734: E-Light Line (2010), 2 descendants of its own
- K124064: Young Again (2013), 1 descendant of its own
- K162556: Lightfusion Led System (2017), 0 descendants of its own

## Indications for use
The PhotoNova Family of Pulsed Light Systems is designed for use in dermatology applications including: · The removal of unwanted hair form all skin types and to effect stable long-term or permanent hair reduction · The treatment of benign pigmented lesions, including lentigines, nevi, melasma and caf6-au-lait * The treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, ttelangiectasias, rosacea, facial and leg veins · Treatment of inflammatory acne (acne vulgaris)

Source page: https://510kreport.com/device/K073477
Methodology: https://510kreport.com/methodology