(87 days)
The Diode Laser Hair Removal System 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.
808nm diode laser using selective light absorption, the Diode 808 laser is preferentially absorbed by the melanin of the hair. The light energy is taken up by the hair follicle and converted to heat energy, and minimal energy is transferred to the skin. This preferentially heats the hair and its DNA, while reducing oxygen organization around hair follicle - reducing the chance of hair regrowth. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.
Diode Laser Hair Removal is the safest and fastest at the present. It 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 provided document is a 510(k) summary for the Diode Laser Hair Removal System (SH-VD910). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria for performance in terms of hair removal. The document explicitly states: "No clinical study is included in this submission." Therefore, it does not contain information about:
- A table of acceptance criteria and reported device performance (in terms of hair removal efficacy).
- Sample size used for a test set for clinical performance.
- Data provenance for a clinical test set.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a clinical test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used for performance validation.
- Sample size for a training set.
- How ground truth for a training set was established.
Instead, the document details non-clinical tests to demonstrate that the new device meets safety and performance standards equivalent to a predicate device, focusing on technical specifications and compliance with recognized standards.
Here's the relevant information that is provided:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide specific quantitative acceptance criteria for hair removal efficacy and corresponding reported performance metrics (e.g., percentage hair reduction). Instead, it compares technical specifications of the proposed device to a predicate device and states that the proposed device complies with various safety and electrical standards.
| Item | Acceptance Criteria (Implied by Predicate & Standards Compliance) | Reported Device Performance (Proposed Device) |
|---|---|---|
| General Comparison | ||
| Device Name | Diode Laser Hair Removal System (Predicate) | Diode Laser Hair Removal System |
| Classification Regulation | 21 CFR 878.4810 (Predicate) | 21 CFR 878.4810 |
| Classification Panel | General & Plastic Surgery (Predicate) | General & Plastic Surgery |
| Class | II (Predicate) | II |
| Product Code | GEX (Predicate) | GEX |
| Common Name | Powered Laser Surgical Instrument (Predicate) | Powered Laser Surgical Instrument |
| Indication for Use | Hair removal, permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin, permanent reduction measured at 6, 9, and 12 months (Predicate) | Hair removal, permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin, permanent reduction measured at 6, 9, and 12 months |
| Prescription Use | Prescription use (Predicate) | Prescription use |
| Performance Comparison (Technical) | ||
| Laser Type | Diode laser (Predicate) | Diode laser |
| Laser Classification | Class IV (Predicate) | Class IV |
| Laser Wavelength | 808nm (Predicate) | 808nm |
| Spot Size | 1.44 cm² (Predicate) | 10mm x 12mm (Different, deemed not to impact safety/effectiveness due to energy output and testing) |
| Fluence | 1-120 J/cm² (Predicate) | 5-120 J/cm² (Different, deemed minor and not to affect effectiveness/safety) |
| Frequency | 0.5-15Hz (Predicate) | 0.5-10Hz (Within predicate range, deemed not to raise new safety issues) |
| Pulse Duration | 5-400ms (Predicate) | 10-300ms (Within predicate range, deemed minor and not to affect effectiveness/safety) |
| Power Supply | AC 110V/60Hz (Predicate) | 110-120 VAC, 15A Max., 60 Hz (Different, but electrical safety and EMC tested) |
| Dimension | 450mm× 550mm×380mm (Predicate) | 78(L)*65(W)*133(H)cm (Different, mechanical performance acceptable per IEC 60601-1) |
| Weight | 52 Kg (Predicate) | 54 kg (Different, mechanical performance acceptable per IEC 60601-1) |
| Safety Comparison | ||
| Electrical Safety | Comply with IEC 60601-1 (Predicate) | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 (Predicate) | Comply with IEC 60601-1-2 |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825-1 (Predicate) | Comply with IEC 60601-2-22, IEC 60825-1 |
| Cytotoxicity | No Cytotoxicity (Predicate) | No Cytotoxicity |
| Irritation | No evidence of irritation (Predicate) | No evidence of irritation |
| Sensitization | No evidence of sensitization (Predicate) | No evidence of sensitization |
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical study was conducted.
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 was conducted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical study was conducted.
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 hair removal system, not an AI-assisted diagnostic tool. No clinical study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device is a laser hair removal system, not an algorithm. No clinical study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical study was conducted. The ground truth for the non-clinical tests is based on compliance with established international standards (e.g., IEC, ISO).
8. The sample size for the training set: Not applicable, as this is a laser device, not a machine learning algorithm.
9. How the ground truth for the training set was established: Not applicable, as this is a laser device, not a machine learning algorithm.
Non-Clinical Test Conclusions:
The manufacturer performed non-clinical tests to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. These tests demonstrated compliance with the following standards:
- IEC 60601-1 Edition 3.2 2020-08 (Medical electrical equipment - General requirements for basic safety and essential performance)
- IEC 60601-1-2 Edition 4.1 2020-09 (Medical Equipment - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests)
- IEC 60825-1:2014 (Safety of laser products - Part 1: Equipment classification, and requirements)
- IEC 60601-2-22: 2012 (Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment)
- ISO 10993-5: 2009 (Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity)
- ISO 10993-10 Fourth edition 2021 (Biological evaluation of medical devices - Part 10: Tests for skin sensitization)
- ISO 10993-23 First edition 2021-01 (Biological evaluation of medical devices - Part 23: Tests for irritation)
The conclusion is that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K162659) based on these non-clinical tests.
§ 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.