(175 days)
LUCID L Y, the laser system is indicated for: the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
1064nm Wavelength: Tattoo removal: dark ink (black, blue and brown) Removal of Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation. Treatment of Common Nevi, Melasma Skin resurfacing procedures for the treatment of acne scars and wrinkle
The LUCID LY . Nd: YAG laser system produces a one pulsed beam, 1064 nm Infrared light laser oscillation in tubes; power supplies, with non-contacted mode and consists of main function,
laser tube : placed in the mixed crystals of copper pipe to the heater and produces a laser beam,
Resonator : amplifies the beam, through the Xe-gas contained lamp : Xe-gas contains high pressure lamp to increase specific laser beam lamp
This converted light energy creates the ND:YAG crystal and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the Tissue by means of an articulated arm and a specially designed multi spot Hand Piece.
The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch.
This system also consist of
Optic main Bench assembly, Fiber optic Hand pieces, LCD control panel, Cooling system. Foot Pedal Switch
The provided document is a 510(k) summary for the LUCID LY laser system (K140837). This document explicitly states that no clinical or non-clinical performance test data was provided in this submission (Page 4, Section 6. Performance test).
Therefore, based on the provided document, the device (LUCID LY) does not have reported performance data or an acceptance criteria study that proves its performance in the context of clinical efficacy (e.g., tattoo removal, acne scar treatment). The submission focuses on demonstrating substantial equivalence to a predicate device (Spectra / K113588) based on technical characteristics and intended use.
However, I can extract the general information requested, noting the absence of performance data.
Here's the breakdown of the information based on the document:
1. A table of acceptance criteria and the reported device performance
- Since no clinical performance data was provided, there are no specific clinical acceptance criteria or reported device performance metrics in this document. The device is being cleared based on substantial equivalence to a predicate device, assuming similar safety and effectiveness based on technical characteristics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No clinical tests were performed or provided in this submission to evaluate the device's performance against specific clinical outcomes.
- Data Provenance: Not applicable.
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 tests were performed or provided in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical tests were performed or provided in 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 surgical instrument, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC study is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a laser surgical instrument, not an algorithm, and its performance is inherently human-in-the-loop (operated by a physician).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for clinical performance. The "ground truth" for this submission revolves around demonstrating that the technical specifications and intended use of LUCID LY are substantially equivalent to the predicate device (Spectra / K113588), implying similar safety and effectiveness.
8. The sample size for the training set
- Not applicable. No clinical data or training sets were used for an algorithm in this submission.
9. How the ground truth for the training set was established
- Not applicable. No clinical data or training sets were used for an algorithm in this submission.
Summary based on the document:
The K140837 submission for the LUCID LY laser system does not include performance criteria or a study demonstrating the device meets such criteria through clinical testing. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (K113588 Spectra) based on technical specifications (e.g., laser type, wavelength, pulse width, fluence, spot size, repetition rate) and intended uses. The document states: "Clinical and Non-Clinical performance test data was not provided in this submission. But, manufactured in accordance with both mandatory and voluntary standard." (Page 4, Section 6). The conclusion states: "LUCID LY, Nd: YAG laser system, in this submission, is substantially equivalent to several already cleared predicate device in respect to the Intended use. Main function, Technology, Principal operation and performance. And every Safety test report show it as safe and effective as predicate device and it does not raise any additional issues for safety and effectiveness." (Page 4, Section 9).
§ 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.