(87 days)
The InMode Diolaze XL System with the Diolaze XL 810mm Hand piece is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction is hair counts at 6, 9 or 12 months following a treatment regimen. The InMode Diolaze XL System with the Diolaze XL 755/810nm & 810/1064nm Hand pieces is intended for hair removal.
The InMode Diolaze XL multisystem (manufactured by InMode MD Ltd.) is a laser based technology platform system utilizing different hand pieces for laser hair removal procedures. The Diolaze XL system was already FDA cleared in K170738 along with its designated Diolaze 810nm hand piece. The InMode Diolaze XL System is designed to deliver optical energy to the skin via a pre-cooled sapphire block. The good optical contact between the sapphire block and skin is achieved by using water based gel. The device provides individual adjustment of light fluence and pulse duration to achieve maximum efficiency and safety for each patient. The handpiece has integrated skin cooling to enhance safety and comfort of the treatment. The InMode Diolaze XL System consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. The diode laser hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises the InMode Diolaze XL System with 20 diode laser bars stacked vertically. The diode is enclosed to the sapphire light guide. The diode laser produces up to 3000W peak optical power. The InMode Diolaze XL System utilizes three add-ons diode laser hand pieces: Diolaze 810nm Hand piece (FDA cleared in K17078), Diolaze 755/810nm Hand piece, Diolaze 810/1064nm Hand piece.
This document describes the FDA 510(k) summary for the InMode Diolaze XL System, a laser device for hair removal. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and detailed study results as might be found in a clinical trial report.
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1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for device performance based on hair reduction percentages. Instead, it relies on demonstrating "significant reduction in hair count" to show efficacy, aligning with the "permanent hair reduction" indication. The performance is compared to the effects observed with predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Hair removal and permanent hair reduction (stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regimen for 810nm handpiece) | "Significant reduction in hair count was demonstrated for both hand pieces and at both treatment areas." |
| Effective hair removal (for 755/810nm & 810/1064nm handpieces) | An average hair reduction of 49.2% was reached. |
| No significant safety concerns | "No adverse events were reported in the study." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 31 female subjects.
- Data Provenance: The study was "multicenter" but the specific country of origin is not explicitly stated. Given that InMode MD Ltd. is based in Israel, it is plausible the study was conducted there or in another country. The study was prospective, described as a "proscription, open labelled, multicenter, single arm Clinical study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Three independent, blinded evaluators.
- Qualifications of Experts: Not specified. The document only mentions "three independent, blinded evaluators" performed photography hair counts.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated, but implies a consensus or averaging approach: "Photography hair counts were performed by three independent, blinded evaluators and a statistical comparison was conducted..." It does not specify if disagreements were resolved through additional review (like 2+1 or 3+1) or if an average or majority vote was used.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Not Applicable. The described study is a single-arm clinical study evaluating the device's efficacy, not a comparative effectiveness study involving human readers with and without AI assistance. The device itself is a laser hair removal system, not an AI-powered diagnostic or assistive tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This is a hardware medical device (laser system), not a software algorithm. The "performance" being evaluated is hair reduction on human subjects.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for hair reduction efficacy was established using photography hair counts performed by independent evaluators, compared to baseline. This can be considered a form of expert consensus/objective measurement based on photographic evidence.
8. Sample Size for the Training Set
- Not Applicable. The device is a laser system and does not involve AI or machine learning algorithms that would typically require a "training set" for model development. The software validation mentioned (IEC 62304) pertains to the safety and functionality of the device's operating software, not to an AI model trained on data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI/ML algorithm requiring a training set, this question is not relevant to the provided information.
§ 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.