# K092734: E-Light Line

- Pathway: 510(k) (Traditional)
- Applicant: Espansione Marketing S.P.A
- Decided: Sep 20, 2010 after 381 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: 16 generations back to K943450 (1995). 250 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 253 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070494: Epi-C Plus, Espansione Marketing S.P.A (2007) Summary page 3.
- K073477: Photonova Family of Pulsed Light Systems, Photonova Ofsweden AB (2008) Summary page 3.
- K031425: Gentlewaves Led Photomodulation Device, Light Bioscience, LLC (2004) Summary page 3.
- K042630: Revlight Skin Care System, Skincare Technology, Inc. (2005) Summary page 3.
- K030426: Omnilux Red, Photo Therapeutics Limited (2003) Summary page 2.
- K030883: Omnilux Blue, Photo Therapeutics Limited (2003) Summary page 3.
- K090762: LEDA, Quantel Derma GmbH (2009) Summary page 2.
- K060792: Illumimed, Photoactif, LLC (2006) Summary page 2.
- K053225: Cellu M6 Keymodule I, Lpg One, Inc. (2006) Summary page 2.

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

## Indications for use
The F-Light Line devices are intended for dermatological use by physicians and healthcare professionals as the following: IPL Technology is intended for: • Treatment of Acne (from 390 to 1200nm filter) * Treatment of vascular and benign pigmented lesions, cutaneous lesions including warts, scars, striae , and facial and leg veins (from 550 tol200nm filter). * Removal of unwanted hair in all skin types (from 570- to 1200nm filter) LED Technology is intended: * Yellow LED 594 nm - for treatment of periorbital wrinkles and rhytides * Blue LED 428nm - to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris * Red LED 632nm - for treatment of superficial, benign vascular and pigmented lesions VACUUM Technology is intended to: *Improve Lymphatic circulation in the treated area

Source page: https://510kreport.com/device/K092734
Methodology: https://510kreport.com/methodology