# K041930: Varilite Laser System

- Pathway: 510(k) (Abbreviated)
- Applicant: Iridex Corporation
- Decided: Sep 10, 2004 after 53 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: 3 generations back to K933880 (1994). 9 ancestors in all.
75 later devices descend from it; 3 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964074: Diolite 532, Iriderm Div. (1997) Summary page 1.
- K951034: Aura Laser System, Laserscope (1995) Summary page 1.
- K024206: Aura Isurgical Laser System & Accessories, Laserscope (2003) Summary page 1.
- K973828: Prima KTP Laser System, Nidek, Inc. (1998) Summary page 1.
- K003993: Dornier Medilas D Skinpulse Laser System (Skinpulse), Dornier Surgical Products, Inc. (2001) Summary page 1.

## Most influential descendants
- K091534: Lightlas Model 532 (2009), 72 descendants of its own
- K100558: Quanta Diode Laser System (2010), 68 descendants of its own
- K102755: Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/ 1470NM Fiber-Coupled Diode Laser (2010), 46 descendants of its own
- K110080: Radial-Emitting Shaped Fiber Optic Delivery System (2011), 26 descendants of its own
- K120810: Fiberoptic Laser Delivery System (2012), 24 descendants of its own

## Indications for use
The VariLite Laser System is intended for use in dermatological applications: The 532 nm wavelength delivered with VariLite handpieces. DioLite 532 handnieces. and ScanLite Scanner is indicated for: * the treatment of vascular lesions including: - Telangiectasia - Cherry Angiomas - Leg Veins - Neovascularization - Spider Angiomas - Port Wine Stains - Roscea - Venous Lakes * the treatment of benign pigmented lesions including: - Lentigines - Freckles - Dernnatosis Papulosis Nigra - Poiklodenna of Civatte - Caf& au- lait Stains - Melasma * the treatment of cutaneous lesions including: - Verruca - Keratoses - Skin Tags * the treatment of moderate inflammatory acne vulgaris. The 940 nm wavelength delivered with VariLite handpieces is indicated for: * the treatment of vascular lesions including: - Telangiectasia - Cherry Angiomas - Leg Veins - Neovascularization - Spider Angiornas - Port Wine Stains - Roscea - Venous Lakes * the treatment of benign pigmented lesions including: - Lentigines - Freckles - Dermatosis Papulosis Nigra - Poiklodenna of Civatte - Caf6- au- lait Stains - Melasma * hair removal

Source page: https://510kreport.com/device/K041930
Methodology: https://510kreport.com/methodology