(90 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.
Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary:
This device is a Diode Laser Hair Removal System. The provided document is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical trial results for novel devices. Therefore, a clinical study documenting device performance against specific acceptance criteria for efficacy (e.g., hair reduction percentage) is explicitly stated as not included in this submission. The acceptance criteria primarily revolve around demonstrating safety and performance equivalence through non-clinical testing.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety | Electrical Safety: Compliance with IEC 60601-1, IEC 60601-2-22. | Complies with IEC 60601-1, IEC 60601-2-22. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2. | Complies with IEC 60601-1-2. | |
| Laser Safety: Compliance with IEC 60601-2-22, IEC 60825-1. | Complies with IEC 60601-2-22, IEC 60825-1. | |
| Biocompatibility (Patient Contact Materials): | ||
| - Cytotoxicity: No cytotoxicity. | No Cytotoxicity (compliant with ISO 10993-5). | |
| - Sensitization: No evidence of sensitization. | No evidence of sensitization (compliant with ISO 10993-10). | |
| - Irritation: No evidence of irritation. | No evidence of irritation (compliant with ISO 10993-23). | |
| Performance | Functionality under varying power supply: Device to work normally under specified power supply ranges (100V-240VAC / 50Hz-60Hz) despite differences from predicate device. | Electrical safety and EMC tests conducted; test results show the device works normally under its specified power supply. |
| Functional Equivalence despite minor differences in Fluence and Pulse Duration: The minor differences in Fluence (Proposed: 1-40J/cm² vs. Predicate: 48J/cm²) and Pulse Duration (Proposed: 3-300ms vs. Predicate: 1-300ms) are not to affect effectiveness and safety. | The manufacturer states that the minor differences in fluence and pulse duration are not expected to affect effectiveness and safety. This is supported by the device having passed the various IEC safety and performance tests. The pulse duration of the proposed device is also noted to be within the range of the predicate device (though the lower limit differs). This acceptance is based on engineering rationale and compliance with safety standards rather than comparative clinical performance. | |
| Indications for Use | Hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction defined as long-term, stable reduction in hair regrowth at 6, 9, 12 months post-treatment. | The device claims these indications, identical to the predicate device. This is a statement of intended use, not a performance metric demonstrated in the submission. |
Study Proving Device Meets Acceptance Criteria
This 510(k) submission explicitly states: "No clinical study is included in this submission."
The "study" or evidence provided to meet the acceptance criteria is primarily a non-clinical testing report demonstrating compliance with recognized safety and performance standards, and a comparison to the predicate device's specifications.
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Sample size used for the test set and the data provenance: Not applicable for a clinical study, as none was included. For non-clinical tests, the "sample" would refer to the device itself or its components. The provenance of the data is from in-house testing and external laboratory testing for standard compliance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical tests is established by adherence to recognized international standards (e.g., IEC, ISO) and laboratory testing protocols.
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Adjudication method for the test set: Not applicable. Non-clinical tests typically involve objective measurements against pass/fail criteria defined by the standards.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable for this type of device and submission (no clinical study was conducted).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (laser system), not an AI algorithm.
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The type of ground truth used:
- For Safety Criteria: Adherence to established international consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22 for electrical and laser safety; ISO 10993-5, ISO 10993-10, ISO 10993-23 for biocompatibility). These standards define the test methods and acceptance limits that constitute "ground truth" for safety.
- For Performance (Functional Equivalence): Engineering rationale comparing the proposed device specifications (Fluence, Pulse Duration, Power Supply) to the predicate device, asserting that minor differences do not impact safety or effectiveness, supported by successful completion of the aforementioned non-clinical safety standards.
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The sample size for the training set: Not applicable, as no clinical study or machine learning component (requiring a training set) was mentioned or conducted.
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How the ground truth for the training set was established: Not applicable.
§ 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.