(162 days)
755 nm Indications for Use:
The 755 nm Profile Multi-Platform System with its accessories is indicated for stable long-term, or permanent hair reduction for all skin types (Fitzpatrick I - VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions and wrinkles.
1320 nm Indications for Use:
The 1320nm Profile Multi-Platform System with its accessories is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Profile 1320nm laser is further indicated for laser assisted lipolysis.
2940 nm Indications for Use:
The 2940 nm Profile Multi-Platform System with Profractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.
The Profile Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.
The provided text is a 510(k) Summary for the Sciton, Inc. Profile Multi-Platform System (K081352). This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested fields cannot be directly extracted from the provided text.
Here is an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report specific performance metrics from a study to demonstrate device performance against such criteria. The submission relies on demonstrating substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance
Not applicable. The document does not describe a clinical performance study with a test set. It is a 510(k) submission based on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a clinical performance study involving experts to establish ground truth.
4. Adjudication method for the test set
Not applicable. The document does not describe a clinical performance study with a test set requiring adjudication.
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/light system, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a laser/light system, not an algorithm or AI product.
7. The type of ground truth used
Not applicable. The document does not describe a study involving ground truth. The submission's argument for safety and effectiveness is based on the technological characteristics and indications for use being substantially equivalent to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. The document does not describe a training set for an algorithm or AI model.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a training set for an algorithm or AI model.
§ 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.