(192 days)
The Lotus II Pulsed Er:YAG Laser System is a pulsed erbium doped yttrium-aluminum-garnet (Er:YAG) laser. It outputs laser light with a wavelength of 2940 nm, a wavelength very efficiently absorbed by the skin. It is intended for coagulation, vaporization, ablation and/or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and ophthalmology (skin around the eyes). This includes skin resurfacing and the treatment of wrinkles
The Lotus II Er:YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).
The Lotus II laser system is an Erbium:YAG laser with a wavelength of 2.94 um. Laser activation is by footswitch. Three basic elements of operations are as follows:
- A Er:YAG crystal is used as a gain medium which produces a laser beam.
- A resonator then amplifies the beam.
- A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Er:YAG crystal – a gain medium – and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit.
Here's the analysis of the provided text regarding the acceptance criteria and study for the Lotus II Pulsed Er:YAG Laser System:
Acceptance Criteria and Device Performance Study for Lotus II Pulsed Er:YAG Laser System (K083253)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Demonstrated by substantial equivalence to predicate devices (DermaStar Er:YAG Laser System (K014057) and MCL 30 Dermablate Er:YAG Laser System (K042968)). |
| Intended Use | Same or very similar to predicate devices: coagulation, vaporization, ablation and/or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and ophthalmology (skin around the eyes). Includes skin resurfacing and treatment of wrinkles. |
| Technical Specifications | Not explicitly stated as acceptance criteria but implied to be comparable to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set data, sample size, or data provenance (e.g., country of origin, retrospective/prospective) are provided in this 510(k) summary. The submission focuses on substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No ground truth was established from an expert panel for this submission as a "performance data" study was not conducted. The determination was based on substantial equivalence to existing devices.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method was used for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. There is no mention of an MRMC comparative effectiveness study in the provided document. The device's approval was based on substantial equivalence, not a clinical effectiveness study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a laser system, not an algorithm or AI-driven diagnostic tool. Therefore, a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used
No direct ground truth was established through clinical data for the Lotus II Pulsed Er:YAG Laser System. The "ground truth" for its acceptance was the established safety and effectiveness of the predicate devices to which it claims substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device seeking 510(k) clearance based on substantial equivalence to predicate devices, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process described.
§ 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.