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510(k) Data Aggregation
(99 days)
The Diode Laser Therapy Systems 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 Therapy Systems is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI); The Diode Laser Therapy 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 handpiece. The emission laser is activated by a foot-switch. The Diode Laser Therapy Systems utilize the principle of photoepilation for hair removal. The Photoepilation is a technique for removal of unwanted hair by thermal destruction of the hair follicle and its reproductive system (stems cells). The heat is caused by selective absorption of electromagnetic radiation emitted by laser light sources. As melanin is the main chromophore existing in hair follicles, so the melanin could absorb the energy from the laser, which would result in temperature rapid increase, then the hair follicle and its reproductive system (stems cells) would be destroyed by increased high temperature without damage epidermis and the surrounding normal tissue.
The provided text is a 510(k) summary for a medical device (Diode Laser Therapy Systems) and does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically found in clinical study reports with specific performance metrics (e.g., sensitivity, specificity, accuracy).
Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and general safety standards.
Therefore, many of the requested fields cannot be directly populated from the provided text. However, I can extract information related to the device's technical specifications and the non-clinical tests performed to support its safety and performance.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not specify formal "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, etc.) that the device must meet. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through:
- Matching intended use and fundamental technology.
- Complying with recognized safety and performance standards (IEC, ISO).
- Showing that any differences in technical specifications do not raise new questions of safety or effectiveness.
| Criteria Type (based on substantial equivalence) | Acceptance/Comparison Goal | Proposed Device Performance/Finding |
|---|---|---|
| Intended Use | Same as predicate | Hair removal, permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. |
| Regulatory Information | Same Classification, Regulation, Product Code as predicate | Class II, 21 CFR 878.4810, GEX, General & Plastic Surgery Review Panel. |
| 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 ± 2nm |
| Fluence | Same as predicate (1-100 J/cm²) | 1-100 J/cm² |
| EMC, Electrical & Laser Safety | Comply with relevant IEC standards (60601-1, 60601-1-2, 60601-2-22, 60825) | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1. |
| Biocompatibility | Comply with ISO 10993 series (Cytotoxicity, Sensitization, Irritation) for patient contact materials. | No Cytotoxicity, No evidence of sensitization, No evidence of irritation (for 6061 Aluminum, Sapphire, ABS). Complies with ISO 10993-5, ISO 10993-10. |
| Spot Size | Non-clinical tests show differences do not affect therapeutic effect and meet requirements. | 15mm × 15mm (different from predicate 1.44 cm² but tested to meet requirements). |
| Frequency | Within predicate’s range; bench tests support substantial equivalence and no new safety issues. | 1-10Hz (compared to predicate's 1-20 Hz, within range). |
| Pulse Duration | Slight difference, within predicate’s range, no new safety issues, bench tests support substantial equivalence. | 1-300ms (compared to predicate's 10-400ms, slight difference deemed safe). |
| Power Supply | Complies with IEC 60601-1 and 60601-1-2, no effect on effectiveness/safety. | 110 Va.c. 60Hz 2000W (different from predicate but tested safe). |
| Dimension/Weight | Complies with IEC 60601-1 for mechanical performance, no effect on substantial equivalence. | Different from predicate (460x390x1230mm, 75Kg vs 560x380x1180mm, 60Kg). Tested to be mechanically safe. |
2. Sample size 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 "test set" in the context of clinical data, no sample size, and no data provenance relevant to clinical performance. The testing mentioned (non-clinical) refers to bench testing on the device hardware and materials.
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. No clinical test set with ground truth established by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
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 therapy system, not an AI-assisted diagnostic or imaging device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm. Performance was assessed through non-clinical bench testing of the physical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" or reference for compliance is established by international standards (IEC, ISO) for electrical safety, laser safety, electromagnetic compatibility, and biocompatibility, as well as the technical specifications of the predicate device.
8. The sample size for the training set
- Not applicable. No AI model or training set is mentioned as this is a physical medical device.
9. How the ground truth for the training set was established
- Not applicable. No AI model or training set is mentioned.
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