(82 days)
The GME LinScan System with the applicators LinScan 808 and LinScan 980 is indicated for hair removal and permanent hair reduction defined as the stable, long term reduction in hair counts at 6, 9,or 12 months following a treatment regime.
The LinScan is a diode laser system designed to be used in Dermatological practice for stable, long term hair reduction. The LinScan System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button), which controls an applicator unit. The applicator unit contains the diode laser and scanner. The unit comes in two models: the LinScan 808 has an applicator with a 808 nm diode laser. The LinScan 980 has an applicator with a 980 nm diode laser. The LinScan System includes the following accessories: Power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit. A cooled sapphire is the only patient contacting part of the system. There are no single use parts in the LinScan System. Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.
The provided document, K141063 does not contain information on testing results that demonstrate the device meets acceptance criteria. The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.
Key observations:
- No Acceptance Criteria Table: The document does not include a table outlining specific acceptance criteria for device performance.
- No Reported Device Performance: While the document lists device specifications (e.g., fluence, pulse widths, wavelength), it does not present performance data from a study to show how the device actually performed against any predefined acceptance criteria.
- Focus on Substantial Equivalence: The "Performance Data" section ([4] K141063, H. Performance Data) exclusively mentions adherence to IEC standards (IEC 60825-1 and IEC 60601-2-22) for electrical and laser safety, which are general safety and performance standards for laser products, not specific clinical or technical performance acceptance criteria for hair reduction.
- No Clinical Study Details: There is no mention of a human clinical study, sample sizes, data provenance, ground truth establishment methods, or expert involvement for evaluating the device's efficacy in hair removal or permanent hair reduction. The indications for use mention "stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime," which implies a need for clinical data to substantiate, but such data is not provided in this summary.
Therefore, many parts of your request cannot be fulfilled based on the provided input.
However, I can provide a general understanding of what such a table would look like and address the limited information available:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the provided document does not include specific acceptance criteria or performance data for hair removal/reduction efficacy. If it did, a table might look something like this (hypothetical example):
| Acceptance Criterion (Hypothetical) | Required Performance (Hypothetical) | Reported Device Performance (Not found in document) | Pass/Fail |
|---|---|---|---|
| Primary Endpoint: Hair Reduction Percentage | ≥ 20% hair reduction at 6 months | No performance data reported | N/A |
| Secondary Endpoint: Subject Satisfaction | ≥ 70% of subjects satisfied | No performance data reported | N/A |
| Safety Endpoint: Incidence of Adverse Events (e.g., burns) |
§ 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.