(183 days)
Treatment of pigmented lesions.
The Medlite\755 Alexandrite Laser is a flashlamp excited Q-switched solid state laser producing a broadband wavelength of 755 ±25nm. Medlite\755™ Alexandrite Laser System is currently marketed under K935631, SE date 08/23/94, for tattoo removal.
Here's an analysis of the provided text regarding acceptance criteria and study information:
Analysis of Acceptance Criteria and Study Information for Medlite™ Alexandrite Laser System (K96006)
It's important to note that this 510(k) summary (K96006) for the Medlite™ Alexandrite Laser System states “none” for both nonclinical and clinical performance data. This indicates that the device's substantial equivalence was based on direct comparison to a predicate device (Cynosure's PhotoGenica T10 Laser, K950684) with similar characteristics, rather than new performance data or a specific clinical study for this premarket notification.
Therefore, many of the requested fields related to a detailed performance study cannot be filled based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this 510(k) summary. | The device is described as a "flashlamp excited Q-switched solid state laser producing a broadband wavelength of 755 ±25nm." Its operation parameters (indications, target chromophore, delivery system, spot size, mode of operation, exposure duration, average laser power, energy to lesion aiming beam, laser wavelength) are stated to be "all within the parameters currently in use by other systems which have been previously found to be substantially equivalent." |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable (no new clinical performance data was provided for this 510(k)).
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable.
4. Adjudication method for the test set
- Not applicable.
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
- No MRMC study was done (this device is a laser system, not an AI-assisted diagnostic tool).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable (this is not an algorithm-only or AI device).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The basis for clearance was substantial equivalence to a predicate device, not new ground truth establishment.
8. The sample size for the training set
- Not applicable (no new clinical or AI training data provided).
9. How the ground truth for the training set was established
- Not applicable.
§ 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.