(131 days)
The Diode Laser Therapy Systems are intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The Diode Laser Therapy Systems mainly consist of console, treatment hand piece and a foot switch. The diode laser emits wavelength of 808nm from the treatment hand piece, the wavelength effectively penetrates deep into and absorbed by the target chromophore. The adequate pulse duration, energy density and epidermal cooling ensure an adequate thermal damage to the target tissue without damaging the surrounding tissue to achieve effective hair removal.
Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
Note: This document is a 510(k) summary for a medical device (Diode Laser Therapy Systems, Model SDL-B) and focuses on establishing substantial equivalence to a predicate device, not necessarily on demonstrating clinical efficacy through a traditional comparative effectiveness study with pre-defined acceptance criteria for performance metrics like sensitivity or specificity. The "acceptance criteria" here refer to meeting regulatory standards and demonstrating equivalence in function and safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard Met | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | To be substantially equivalent to the predicate device for hair removal and permanent hair reduction on all skin types (Fitzpatrick I-VI), with a definition of permanent hair reduction as long-term, stable reduction measured at 6, 9, and 12 months post-treatment. | The proposed device, Diode Laser Therapy Systems, has the same intended use as the predicate device (Emvera Diolux, K123257). Both are intended for hair removal and permanent hair reduction on all skin types (Fitzpatrick I-VI), with the same definition for permanent hair reduction. |
| Technological Equivalence | Demonstrate similar technological characteristics or that differences do not raise new questions of safety or effectiveness. | Wavelength: Same (808 nm) |
| Fluence (Energy Density): Same ( |
§ 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.