(77 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.
The diode laser system is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.
The proposed system provides two working modes, which are standard hair removal mode (HR) and fast hair removal mode (FHR). They are different in the combination of frequency and fluence. Compared with HR mode, the FHR Mode (Fast Hair Removal) has low fluence and high repetition rate (10Hz).
The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black); in addition, the treatment can also be applied to different parts of the body, including Axillary, Chest, Arm, Back, Leg, Hairline, Cheek, Lip, Beard, and Bikini;
The provided document describes a 510(k) premarket notification for a Diode Laser Hair Removal System L808. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with acceptance criteria and a study to prove performance.
Therefore, many of the requested items (e.g., acceptance criteria, detailed study design, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or available in this document. The submission explicitly states: "No clinical study is included in this submission."
However, I can extract information related to the non-clinical tests and the comparison to the predicate device, which serves as the basis for the substantial equivalence determination.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., percentage of hair reduction, safety outcomes) for the proposed device's approval in this 510(k) summary because no clinical study was conducted. Instead, the "acceptance criteria" are implied by meeting various international safety and performance standards and demonstrating technological similarity to the predicate device.
| Criterion Type | Acceptance Criteria (Implied by Standards & Predicate Comparision) | Reported Device Performance (as demonstrated by non-clinical tests and comparison to predicate) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1:2005 (General Requirements for Basic Safety and Essential Performance) and IEC 60601-2-22:2007 (Specific Requirements for Surgical Laser Equipment). | "The test results demonstrated that the proposed device complies with... IEC 60601-1:2005" and "...IEC 60601-2-22:2007." |
| Laser Safety | Compliance with IEC 60825-1: 2007 (Safety of laser products - Part 1: Equipment classification and requirements). | "The test results demonstrated that the proposed device complies with... IEC 60825-1: 2007." |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2:2007 (General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests). | "The test results demonstrated that the proposed device complies with... IEC 60601-1-2:2007." |
| Biocompatibility | Compliance with ISO 10993-5:2009 (Tests for Vitro cytotoxicity) and ISO 10993-10:2002/Amd. 1: 2006 (Test for irritation and delay-type hypersensitivity). | "The test results demonstrated that the proposed device complies with... ISO 10993-5:2009" and "...ISO 10993-10:2002/Amd. 1: 2006." |
| Technological Characteristics | Specifications (e.g., laser type, wavelength, power, modes, fluence, frequency, pulse duration) should be substantially equivalent to the predicate device. The intended use must also be substantially equivalent. | The comparison table (Table 1) shows that the proposed device has the same product code, regulation number, intended use (with slightly more detailed definition of permanent hair reduction), configuration, treatment modes, principle of operation, laser type, laser classification, laser wavelength, fluence ranges (HR mode matching, FHR mode proposed up to 25 J/cm² vs predicate ≤ 10 J/cm²), and frequency (HR mode matches, FHR mode 10Hz matching). Spot size is 1.44 cm² vs 1.2 cm² for predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No clinical study (test set) was conducted or presented in this 510(k) submission. Non-clinical tests listed are primarily engineering and bench testing, not human subject data.
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 requiring expert ground truth was established within this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set requiring adjudication was established within this submission.
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 system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a hardware device (laser system), not an algorithm. Therefore, standalone algorithm-only performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable for clinical performance. For the non-clinical tests, the "ground truth" is defined by the technical specifications outlined in the referenced IEC and ISO standards. For the substantial equivalence comparison, the "ground truth" is the established technological characteristics and intended use of the legally marketed predicate device.
8. The sample size for the training set
- Not Applicable. No training set for an algorithm was used as no AI/software algorithm for clinical interpretation is part of this device submission.
9. How the ground truth for the training set was established
- Not Applicable. As no training set was used, no ground truth for it was established.
§ 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.