(56 days)
The Diode Laser Hair Removal System (Model: MBT-Diode Laser) 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.
Diode Laser Hair Removal System (Model: MBT-Diode Laser) is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). The Dermatological Diode Laser Systems utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handle. The emission laser is activated by footswitch or handle button.
The Diode Laser Hair Removal System consists of the following major components
- The main console unit that incorporates the main CPU board, power supply modules, laser power supply, laser device, cooling system and switching module
- Handpiece
- Footswitch
The provided text is a 510(k) Summary for a Diode Laser Hair Removal System (MBT-Diode Laser). It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not outline specific, quantified acceptance criteria for the new device as would be seen in a clinical study. Instead, it demonstrates substantial equivalence to a predicate device by comparing technical specifications and adherence to recognized standards.
The table below summarizes the technical comparison provided, where "acceptance criteria" can be interpreted as demonstrating equivalence or justification for differences compared to the predicate/reference devices:
| Feature | Acceptance Criteria (Comparison to Predicate/Reference) | Reported Device Performance (Proposed Device) |
|---|---|---|
| General | ||
| Device Name | NA (for comparison) | Diode Laser Hair Removal System |
| Classification Regulation | SAME as predicate (21 CFR 878.4810) | 21 CFR 878.4810 |
| Classification Panel | SAME as predicate (General & Plastic Surgery) | General & Plastic Surgery |
| Class | SAME as predicate (II) | II |
| Product Code | SAME as predicate (GEX) | GEX |
| Indications for Use | SAME as predicate: Hair removal, permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction defined as long-term, stable reduction measured at 6, 9, and 12 months post-treatment. | Same as criterion |
| Performance (Technical) | ||
| Laser Type | SAME as predicate (Diode Laser) | Diode Laser |
| Laser Classification | SAME as predicate (Class IV) | Class IV |
| Laser Wavelength | SAME as predicate (808nm) | 808nm |
| Spot Size | SIMILAR to predicate (15mm x 15mm vs. 2.25cm², 1.44cm²) | 15mm x 15mm |
| Fluence | Different from predicate (0-120 J/cm²), but justified as lower (55.96 J/cm²) and similar to reference device (48 J/cm²) for effectiveness. Safety ensured by compliance with standards. | 1-55.96 J/cm² |
| Frequency | SAME as predicate (1-10Hz) | 1-10Hz |
| Pulse Duration | Different from predicate (10-400ms), but within predicate range (2-240ms) and considered a minor difference not affecting effectiveness/safety. Safety ensured by compliance with standards. | 2-240ms |
| Power Supply | Different from predicate (220/110 VAC/50Hz-60Hz), but electrical safety and EMC tests conducted ensure normal operation. | 110 VAC/50Hz-60Hz |
| Dimension | Different from predicate (112 cm x 42 cm x 60 cm), but mechanical performance accepted by IEC 60601-1. | 650mm x 580mm x 1210mm |
| Weight | Different from predicate (63Kg), but mechanical performance accepted by IEC 60601-1. | 68Kg |
| Safety | ||
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 (SAME as predicate) | Complies |
| EMC | Comply with IEC 60601-1-2 (SAME as predicate) | Complies |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 (SAME as predicate) | Complies |
| Cytotoxicity | No Cytotoxicity (SAME as predicate; aligns with ISO 10993-5) | No Cytotoxicity |
| Sensitization | No evidence of sensitization (SAME as predicate; aligns with ISO 10993-10) | No evidence of sensitization |
| Irritation | No evidence of irritation (SAME as predicate; aligns with ISO 10993-23) | No evidence of irritation |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no "test set" in the context of clinical performance data. The evaluation relies on non-clinical (bench) testing and comparison to predicate devices, not human subject data.
Since no clinical study was conducted, there is no data provenance (country of origin, retrospective/prospective) for a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no clinical study was conducted and no clinical test set was used, there was no ground truth for a test set established by experts.
4. Adjudication Method for the Test Set
Not applicable. As no clinical study was conducted and no clinical test set was used, there was no adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a hardware product (Diode Laser Hair Removal System), not an algorithm or software-only device. Therefore, the concept of "standalone algorithm performance" as typically applied to AI/software as a medical device (SaMD) is not applicable here. The performance is evaluated based on its physical/electrical characteristics and safety standards.
7. The Type of Ground Truth Used
For the non-clinical tests regarding electrical safety, EMC, laser safety, and biocompatibility, the "ground truth" is defined by compliance with internationally recognized standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993 series). The device's performance is measured against the requirements of these standards.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device submission, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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.