(149 days)
The Diode Laser Therapy Machine is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
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 proposed device, Diode Laser Therapy System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
There are 4 models included, FG 2000, FG 2000-B, FG 2000-C and FG 2000-D, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration.
The main components of proposed device shown as following: Handpiece, Touchscreen, Emergency Switch, Key Switch, Connector, Indicator Lamp, Foot Switch.
The proposed system provides 36 working modes, which are six modes for men and six modes for women, the men or women mode includes face, armpit, arm, body, bikini, leg mode respectively for different treatment part, and each particular treat mode includes three submode as mode 1, mode 2 and mode 3.
The difference for each mode is only the default parameters for each mode can be adjustable in the parameter range.
The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black);
The provided text is related to a 510(k) premarket notification for a Diode Laser Therapy Machine, a device intended for hair removal and permanent hair reduction.
1. Table of acceptance criteria and the reported device performance:
The document describes the device's technical specifications and how they compare to predicate devices, rather than explicit acceptance criteria and performance for clinical outcomes. The "acceptance criteria" here are essentially the standards and safety requirements met, and the "reported device performance" is its adherence to those standards and its technical parameters.
| Acceptance Criteria (Standards/Technical Parameters) | Reported Device Performance (Proposed Device) |
|---|---|
| General | |
| Product Code (GEX) | GEX |
| Regulation Number (21 CFR 878.4810) | 21 CFR 878.4810 |
| Intended Use | Hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. |
| Configuration | Main Unit, Handpiece, Foot Control |
| Principle of Operation | Diode Laser |
| Laser Specifications | |
| Laser Type | Diode Laser |
| Laser Classification | Class IV |
| Laser Wavelength | 808 nm |
| Spot Size | 1.44 cm² |
| Fluence | 2-120 J/cm² |
| Frequency | 1-10 Hz |
| Pulse Duration | 9-143 ms (Noted as different from predicate but covered within predicates' range and not affecting SE) |
| Power Supply | AC 110V/50Hz-60Hz |
| Biocompatibility | |
| Patient Contact Materials | Sapphire in handpiece and handpiece tip (Stainless Steel) |
| Cytotoxicity | No Cytotoxicity (Comply with ISO 10993-5) |
| Sensitization | No evidence of sensitization (Comply with ISO 10993-10) |
| Irritation | No evidence of irritation (Comply with ISO 10993-10) |
| Safety and EMC | |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 |
| EMC | Comply with IEC 60601-1-2 |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825-1 |
| Other Performance | |
| Spot Size Accuracy | Performance Testing conducted |
| Energy Output Accuracy | Performance Testing conducted |
2. Sample size used for the test set and the data provenance:
The submission explicitly states: "No clinical study is included in this submission." Therefore, there is no test set or related data provenance from a clinical study to report. The evaluation relies on non-clinical tests and substantial equivalence to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical study or test set requiring expert ground truth was included.
4. Adjudication method for the test set:
Not applicable, as no clinical study or test set was conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The submission states, "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a hardware-based medical laser system, not an algorithm.
7. The type of ground truth used:
Not applicable for clinical performance. For the non-clinical tests (e.g., biocompatibility guidance, electrical safety, EMC, laser safety), the "ground truth" is defined by the technical standards themselves (e.g., IEC, ISO standards).
8. The sample size for the training set:
Not applicable, as no clinical study or artificial intelligence/machine learning algorithm requiring a training set was used or described.
9. How the ground truth for the training set was established:
Not applicable, as no training set was used or described.
§ 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.