# K043319: Clareon and Solarus Pulsed Light Devices and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Novalis Medical, LLC
- Decided: Dec 17, 2004 after 15 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: 6 generations back to K910422 (1992). 55 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller, Palomar Medical Technologies, Inc. (2002) Summary page 1.
- K040081: Palomar Luxv Handpiece, Palomar Medical Technologies, Inc. (2004) Summary page 1.
- K020941: Palomar Luxg Handpiece, Palomar (2002) Summary page 1.
- K963249: Epilight Hair Removal System, Esc Medical Systems, Ltd. (1997) Summary page 1.
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL, Lumenis, Inc. (2002) Summary page 1.
- K032205: Radiancy Acne System with Cleartouch Light Unit Assembly, Radiancy (Israel), Ltd. (2003) Summary page 1.

## Most influential descendants
- K051508: Med Flash II Intense Pulsed Light System. (2005), 8 descendants of its own
- K072331: Radiancy Mistral Device (2008), 6 descendants of its own
- K091664: GSD Intense Pulsed Light System, Models: GP666C4, GP666C (2009), 4 descendants of its own
- K062048: Aesthera Photopneumatic (PPX) System (2006), 4 descendants of its own
- K083730: Isolaz (2009), 3 descendants of its own

## Indications for use
The ClareonTM and Solarus TM Pulsed Light Systems are light-based medical device(s) intended for use with the following: HR Handpiece - Permanent hair reduction. AR Handpiece - Treatment of inflammatory acne. VR Handpiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions. SR Handoiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions. Removal of unwanted hair.

Source page: https://510kreport.com/device/K043319
Methodology: https://510kreport.com/methodology