(86 days)
The Diode laser therapy device 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 adopts Gold standard 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. Meanwhile, don't hurt around tissues and virtually pain-free remove surplus hair; eventually, reach to permanent Hair Removal.
The Diode laser therapy device 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 handpiece. The emission laser is activated by a foot-switch.
The provided documentation does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria beyond substantial equivalence to a predicate device.
Here's an analysis of the provided information based on your request:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria with numerical targets for performance (e.g., hair reduction percentage, adverse event rate) are presented for the proposed device itself. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K210663). The "performance" reported is primarily a comparison of technical specifications to the predicate device.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as compared to Predicate Device K210663) |
|---|---|
| Product Code is GEX | SAME (GEX) |
| Regulation Number is 21 CFR 878.4810 | SAME (21 CFR 878.4810) |
| Class is 2 | SAME (2) |
| Indication for Use is 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. | SAME |
| Configuration includes Main Unit, Handpiece, Foot Control | SAME |
| Principle of Operation is Diode Laser | SAME |
| Laser Type is Diode Laser | SAME |
| Laser Classification is Class IV | SAME |
| Laser wavelength is 808 nm | SAME |
| Fluence is 5-100 J/cm² | SAME |
| Frequency is 1-10 Hz | SAME |
| Power Supply is AC 110V/60Hz | SAME |
| Complies with IEC 60601-1-2: 2020 | Test results demonstrated compliance |
| Complies with AAMI/ANSI ES 60601-1: 2012 | Test results demonstrated compliance |
| Complies with IEC 60601-2-22: 2019 | Test results demonstrated compliance |
| Complies with IEC 60825-1: 2014 | Test results demonstrated compliance |
| Complies with ISO 10993-5: 2009 | Test results demonstrated compliance |
| Complies with ISO 10993-10: 2010 | Test results demonstrated compliance |
| Complies with ISO 14971: 2019 | Test results demonstrated compliance |
Differences and their analysis for safety and effectiveness:
- Spot Size:
- Proposed: 12mm × 35mm
- Predicate: 10 × 30 mm
- Analysis: "Spot size only affects the area of treatment, not affect the therapeutic effect. Therefore, this difference will not affect the safety and effectiveness."
- Pulse Duration:
- Proposed: 5-200ms
- Predicate: 15-400ms
- Analysis: "The frequency of the proposed device is within the range of that of the predicate device, which can justify that the difference in the parameter of Pulse duration will not raise new safety issues of the proposed device. In addition, we also found a reference device (K181019), which has the same intended use as the reference device. The Pulse Duration of the reference device is 30-200 ms, which is similar to the proposed device's pulse duration, so this difference will not affect the effectiveness of the device."
- Dimension:
- Proposed: 55cm × 55 cm × 123cm
- Predicate: 65cm × 65cm × 123cm
- Analysis: "the dimension and weight difference are just in physical specification and this difference will not raise any issues in safety and effectiveness. By complying with AAMI/ANSV/ES 60601-1, the mechanical performance of the proposed device is determined to be accepted."
- Weight:
- Proposed: 62kg
- Predicate: 75kg
- Analysis: (Same as Dimension)
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no clinical test set, sample size, or specific data provenance (country of origin, retrospective/prospective) for device performance on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical study was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study was performed.
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, as this device is a laser therapy device for hair removal, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of a software algorithm. This device is a hardware laser therapy device, not a standalone algorithm. Therefore, this question is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Since no clinical study was conducted, there is no patient-level ground truth data (like expert consensus, pathology, or outcomes data) specifically for this proposed device. The basis for substantial equivalence relies on the technical specifications and indications for use being similar to a legally marketed predicate device, and the device complying with relevant electrical, laser, and biocompatibility standards through non-clinical testing.
8. The sample size for the training set
Not applicable, as no algorithm or machine learning model requiring a training set is mentioned for this device.
9. How the ground truth for the training set was established
Not applicable, as no algorithm or machine learning model requiring a training set is mentioned for this device.
In summary: The provided FDA 510(k) clearance document for the Diode laser therapy device is based on demonstrating substantial equivalence to a predicate device (K210663) through non-clinical performance testing (compliance with standards) and a comparison of technical specifications, rather than a new clinical study. Therefore, most of the requested information regarding clinical study design, test sets, ground truth, and AI-related metrics is not available in this document.
§ 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.