(567 days)
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.
- Pro handpiece:
· Incision, excision, ablation, vaporization of soft tissue
· The non-ablative treatment of facial wrinkles - Multistation Handpiece:
· Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. - Vektra QS Handpiece:
· Tattoo Removal: Dark Ink: (Black & Blue)
· Nevus of Ota
· Skin resurfacing procedures for the treatment of acne scars and wrinkles - 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 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.
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 handpiece.
The provided text is a 510(k) summary for the medical device "Solon," a modular multifunction laser system. It outlines the device's technical specifications, indications for use, and a comparison with a predicate device to establish substantial equivalence. However, it does not include a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effect sizes for human readers.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (APOLLO V+ Medical Platform K113018) by comparing technological characteristics, safety standards compliance, and performance parameters. The performance evaluation is based on adherence to recognized international regulations and standards, rather than a clinical performance study with defined acceptance criteria and statistical outcomes.
Therefore, many of the requested information points cannot be extracted from this document, as they pertain to clinical performance studies, which were explicitly stated as not performed.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence through technical and safety comparisons, not through meeting specific performance criteria from a clinical study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable. No clinical test set data is presented as "No clinical trial was performed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. No clinical trial was performed, so there was no test set requiring expert ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No clinical trial was performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a laser surgical instrument, not an AI-assisted diagnostic tool. Furthermore, "No clinical trial was performed."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical laser system, not an algorithm. "No clinical trial was performed."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No clinical trial was performed.
8. The sample size for the training set:
Not applicable. No clinical trial was performed.
9. How the ground truth for the training set was established:
Not applicable. No clinical trial was performed.
Information that is available (related to the overall submission):
- Device name: Solon
- Regulation number: 21 CFR 878.4810
- Regulation name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
- Regulatory Class: Class II
- Product Code: GEX
- Predicate Device: APOLLO V+ Medical Platform (K113018) from Beijing Syntech Laser Co., Ltd.
- Indications for Use: Detailed for various handpieces including incision/excision/ablation/vaporization of soft tissue, non-ablative treatment of facial wrinkles, unwanted hair removal, tattoo removal, treatment of Nevus of Ota, skin resurfacing for acne scars and wrinkles, and treatment of benign pigment/vascular lesions.
- Safety Standards Compliance (Non-clinical testing performed against these standards):
- IEC 60601-1:2005 +CORR.1:2006 +CORR.2:2007+A1:2012 (General requirements for basic safety and essential performance)
- IEC 60601-1-2 Edition 4.1 2020-09 (Electromagnetic disturbances)
- IEC 60601-2-22 Edition 3.1 2012-10 (Particular requirements for laser equipment)
- ISO 10993-1: 2018 (Biological evaluation of medical devices - risk management)
- ISO 10993-5: 2009/(R)2014 (Biological Evaluation of Medical Devices - Tests for In vitro Cytotoxicity)
- ISO 10993-10: 2010/(R)2014 (Biological Evaluation of Medical Device - Tests for Irritation and Skin Sensitization)
- Non-clinical Testing: The submission explicitly states, "No clinical trial was performed." The safety and effectiveness are "Based on compliance with the international standard and regulation mentioned above," demonstrating equivalence to the predicates.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.