Solon

Lmg Lasers Comercio, Importacao E Exportacao Ltda

Country / region:Brazil (BR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

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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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