# K221766: Solon

- Pathway: 510(k) (Traditional)
- Applicant: Lmg Lasers Comercio, Importacao E Exportacao Ltda
- Decided: Jan 5, 2024 after 567 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). 244 ancestors in all.
No later device cites it as a predicate yet.
0 of 245 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113018: Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based Platform, Beijing Syntech Laser CO., LTD. (2012) Summary page 5.

## Indications for use
Solon is intended to be use in dermatology, cosmetic surgery, and other surgical applications according to the different handpieces. The specific indications should reference to the indications of each handpiece. 1) Pro handpiece: • Incision, excision, ablation, vaporization of soft tissue • The non-ablative treatment of facial wrinkles 2) Multistation Handpiece: • Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 3) Vektra QS Handpiece: • Tattoo Removal: Dark Ink: (Black & Blue) • Nevus of Ota • Skin resurfacing procedures for the treatment of acne scars and wrinkles 4) IPL Handpiece: The Intense Pulsed Light wavelengths are 515-1200 nm • Multiwave: 650-1200 nm The removal of unwanted hair from skin types l-V, and to effect stable long-term, or permanent hair reduction in skin types I - V through selective targeting of melanin in hair follicules. • Expert Light: 570- 1200nm The treatment of benign pigment (epidermal and cutaneous) lesions, such as warts. • Expert Light: 515-1200nm The treatment of benign vascular lesions including port wine stains, hemangiomas, facial, truncal anf leg telangiectasias, rosacea, melasma, angiomas and spider aglormas, polkilorderma of civatte, leg veins and venous malformations.

Source page: https://510kreport.com/device/K221766
Methodology: https://510kreport.com/methodology