Solon
Lmg Lasers Comercio, Importacao E Exportacao Ltda
Country / Region:Brazil (BR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K221766
- Device name
- Solon
- Country / Region
- Brazil(BR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-06-17
- Decision date
- 2024-01-05
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cuttingSkin tighteningHair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
Solon is intended to be used 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 I-V, and to effect stable long-term, or permanent hair reduction in skin types I - V through selective targeting of melanin in hair follicles. • 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 and leg telangiectasias, rosacea, melasma, angiomas and spider aglormas, polkilorderma of civatte, leg veins and venous malformations.
Intended 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 follicles. • 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 and leg telangiectasias, rosacea, melasma, angiomas and spider aglormas, polkilorderma of civatte, leg veins and venous malformations.
Device Description
The Solon system is a modular multifunction device. The equipment can be used in dermatology, and aesthetic surgery according to the different handpieces. The Solon system has five laser handpieces of Er:YAG laser, Long Pulse Nd:YAG Laser, and Q-Switch Nd:YAG Laser, and two IPL handpieces.
Summary parsed at:2026-06-01 05:26:13 UTC
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Cited as predicate
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