(93 days)
The BIOSYAG MEDICAL SYSTEM is a modular multi-laser and multi-use device for the cosmetic treatment of face and body. It is used to treat common imperfections and lessions of skin and body, including:
- The removal of unwanted hair and to effect stable long term or permanent hair reduction,
- Laser skin treatment procedures for the treatment of: acne scars, wrinkles
- Incision, excision, ablation, vaporisation of soft tissue,
- The non-ablative treatment of facial wrinkles, such as, but not limited to: periocular wrinkles, perioral wrinkles
- Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions.
- Treatment of capillaries, teleangiectasies and vascular lesions.
- Treatment of vitiligo and psoriasis.
The equipment should only be used under medical supervision.
The BIOSYAG MEDICAL SYSTEM is a modular multi-laser and multi-use device for the cosmetic treatment of face and body. It is used to treat common imperfections and lesions of skin and body. The BIOSYAG MEDICAL SYSTEM includes the following light sources: Nd:YAG 50 J (internal laser source) Nd:YAG Q-switched (handpiece) Er:YAG (handpiece) Pulsed Light source. The handpiece is the part that the user grips to carry out the laser treatment and consists of a main body and a removable end section that defines the size of the work beam. At the resonator lead-in an appropriately dimensioned fibre is connected with a focussing device fitted on the end, used to treat the patient. The system is supplied with a set of adapters to be able to use different work beam dimensions. The cooling section consists of a deionised water/air heat exchanger. The foreseen operating cycle is intermittent, operating at maximum power for 10 minutes, followed by a 5 minute pause. The management of the source and the work parameters is by means of a control panel with a liquid crystal colour screen and touch screen functions.
Here's an analysis of the provided 510(k) summary regarding acceptance criteria and study information:
This 510(k) summary for the BIOSYAG MEDICAL SYSTEM (K080374) does not contain any information about acceptance criteria or specific studies undertaken to prove the device's performance. Instead, it relies on a claim of substantial equivalence to predicate devices.
Therefore, many of the requested sections will state "Not Applicable" or that no information is provided in the document.
1. Table of Acceptance Criteria and Reported Device Performance
No acceptance criteria or reported device performance metrics were provided in the document. The submission relies solely on substantial equivalence to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. No test set or clinical study data is presented. The submission relies on substantial equivalence to predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. No ground truth establishment is described as no clinical studies are presented.
4. Adjudication Method for the Test Set
Not Applicable. No test set or clinical data is presented.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Clinical Performance Data: None." Therefore, no MRMC comparative effectiveness study was conducted or reported.
6. Standalone Performance Study
No. The document explicitly states: "Clinical Performance Data: None." No standalone (algorithm-only) performance study was conducted or reported.
7. Type of Ground Truth Used
Not Applicable. As no clinical studies or performance data are presented, no ground truth was established or used for such purposes in this submission.
8. Sample Size for the Training Set
Not Applicable. No training set is mentioned or implied, as no AI/Machine Learning algorithm development or performance data is presented.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. No training set is mentioned or implied, and consequently, no method for establishing ground truth for a training set is described.
Summary of Document Contents Regarding Performance:
The provided 510(k) summary for the BIOSYAG MEDICAL SYSTEM (K080374) does not include any performance data, clinical study results, or specific acceptance criteria for the device itself. The basis for substantial equivalence is primarily drawn from the device's specifications, functionality, indications for use, and treatment parameters being "the same or very similar" to legally marketed predicate devices (Bios Yag 50 Med and APL Medical System). The document explicitly states "Non-Clinical Performance Data: None" and "Clinical Performance Data: None." This indicates that the manufacturer did not submit new performance data for this particular 510(k) submission, instead relying on the demonstrated safety and effectiveness of the identified predicate devices.
§ 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.