(70 days)
The MLT R694 Ruby Laser System (operating in the Q-Switched mode) is indicated for cutting, vaporization, or ablation of soft tissue. This includes tatoo removal and treatment of benign pigmented lesions.
The MLT R694 Ruby Laser System is restricted to sale to or use by licensed professionals in the United States
The MLT R694 laser operates as a normal pulse or as a O-Switched rubv laser which emits a beam of coherent light at 694 nanometers. In the Q-Switched mode the beam has a much shorter pulse duration than in the normal or long pulse mode. The specifications for the normal or long pulse mode remain the same as described in K980187.
The provided document, a 510(k) summary for the MLT R694 Ruby Laser System, states that no performance data was required because "The specifications and intended uses of the MLT R694 ruby system laser operating in the Q-Switched mode are the same or very similar to those of the claimed predicate devices." Therefore, no specific acceptance criteria or studies proving the device meets them are detailed in this document.
The submission relies on substantial equivalence to predicate devices. This means that instead of conducting new performance studies, the manufacturer demonstrated that their device is as safe and effective as other legally marketed devices (predicates) with similar characteristics and intended uses.
Based on the provided text, the following information is not available or not applicable:
- Table of acceptance criteria and reported device performance: Not applicable, as performance data was not required for this 510(k) submission.
- Sample size used for the test set and the data provenance: Not applicable. No test set was used, as performance data was not required.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth was used.
- Adjudication method for the test set: Not applicable. No test set was used.
- 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 system, not an AI-assisted diagnostic tool, and no MRMC study was conducted.
- 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.
- The type of ground truth used: Not applicable. No test set requiring ground truth was used.
- The sample size for the training set: Not applicable. This device is a laser system, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable. This device is a laser system, not an AI model.
Summary of available information regarding the justification for market clearance:
- Basis for Clearance: Substantial Equivalence to legally marketed predicate devices.
- Predicate Devices: LaseAway Long Pulse and Q-Switched Ruby Laser, MM-Ruby Laser; Spectrum RD 1200; Candela AlexLAZR.
- Reason for no performance data: The specifications and intended uses of the MLT R694 ruby system laser operating in the Q-Switched mode are the same or very similar to those of the claimed predicate devices.
- Conclusion: The MLT R694 in Q-Switched mode is substantially equivalent to legally marketed predicate devices. The normal mode operation of the MLT R694 (K980187) was already found substantially equivalent and its characteristics are not affected by the Q-Switched modification.
§ 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.