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510(k) Data Aggregation
(215 days)
The Diode Laser Hair Removal 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 semiconductor laser therapeutic device is mainly composed of a host, the treatment handle, foot switch, power cord, and accessories. The host consists of a control panel, cooling system, circuit control system, semiconductor laser power supply, etc.
The provided document is a 510(k) clearance letter for a Diode Laser Hair Removal Machine (QDTM-02), not a study report. It states that "No clinical study is included in this submission," and therefore, it does not contain the detailed information requested regarding acceptance criteria and a study proving device performance against those criteria.
However, based on the information available in the 510(k) summary, I can infer some aspects related to the intent of testing and acceptance criteria for demonstrating "substantial equivalence."
Inferred Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)
The submission aims to demonstrate substantial equivalence to predicate devices, meaning the acceptance criteria are implicitly tied to matching or falling within acceptable ranges of the predicate devices' specifications and performance, and complying with recognized safety standards.
1. Table of Acceptance Criteria and Reported Device Performance (Inferred)
| Feature/Parameter | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (as per K242951) |
|---|---|---|
| Intended Use | Permanent hair removal/reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction defined as long-term, stable reduction in regrowing hairs at 6, 9, and 12 months post-treatment. | 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. (Matches predicate indication) |
| Laser Type | Class IV Diode Laser (as per predicates K192735, K180353) | Class IV Diode Laser |
| Wavelength | 808nm (as per predicates K192735, K180353) | 808nm |
| Frequency | Within range of predicates (e.g., 1-20 Hz for K180353) | 1-20Hz (Matches Predicate Device 2, K180353) |
| Pulse Duration | Within range of predicates (e.g., 50-400ms for K192735, 10-400ms for K180353) | 10-200ms (Falls within ranges of both predicates) |
| Small Spot Handpiece Size | 1.44 cm² (as per Predicate Device 2, K180353) | 1.44 cm² (Identical to Predicate Device 2) |
| Large Spot Handpiece Size | Within acceptable range, possibly similar to Predicate Device 1 (2.4 cm²) or reference device Eneka Pro (4.75 cm²) | 4 cm² (Differs from Predicate 1, but similar to reference device Eneka Pro; deemed safe/effective) |
| Biocompatibility | Compliance with ISO 10993 series standards. | Test results comply with ISO 10993 series standards (ISO 10993-5, -10, -23 cited). |
| Electrical Safety & EMC | Compliance with relevant IEC standards (e.g., IEC 60601-1, IEC 60601-1-2) | Meets IEC 60601-1 (2005), IEC 60601-1-2 (2014), IEC 60601-2-22 (2019), IEC/TR 60601-4-2. |
| Laser Safety | Compliance with IEC 60825-1 | Meets IEC 60825-1 (2014). |
2. Sample size used for the test set and the data provenance:
- The document explicitly states: "No clinical study is included in this submission."
- Therefore, there is no information on a "test set" in the context of clinical performance data for hair removal.
- The testing mentioned (biocompatibility, electrical safety, EMC, laser safety) would involve samples of the device components or the entire device, tested in a laboratory setting. This is not performance data on patients.
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 test set for performance evaluation is reported.
- For the non-clinical tests (biocompatibility, safety standards), the "ground truth" is defined by the requirements of the standards themselves, not by expert consensus on clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set for performance evaluation requiring expert adjudication is reported.
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 hair removal machine, not an imaging diagnostic device or AI software that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests conducted, the "ground truth" is compliance with established international standards (IEC for electrical and laser safety, ISO for biocompatibility). There is no "outcomes data" or "pathology" cited in the context of device performance on patients.
8. The sample size for the training set:
- Not applicable, as "training set" typically refers to data used to train an algorithm or AI model. This is a physical laser device.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
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