ALEX TA2 ERASER

• K Number: K980131
• Device Name: ALEX TA2 ERASER
• Manufacturer: LIGHT AGE, INC.
• Date Cleared: 1998-02-17 ( 33 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K935631 , K961006

Intended Use

Light and dark ink tattoo removal and pigmented lesions removal

Device Description

The Alex Ta2 Eraser is a flashlamp Q-switched solid state laser producing a broadband wavelength of 755 ±25nm.

AI/ML Overview

The provided text is a 510(k) summary for the Alex Ta2 Eraser, a medical laser system. Upon review, it explicitly states "Nonclinical Performance Data: None provided at this time" and "Clinical Performance Data: None provided at this time."

Therefore, based on the provided document:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or reported device performance are provided as no clinical or nonclinical performance data was submitted. The device was deemed substantially equivalent to a predicate device without this data.
2. Sample sized used for the test set and the data provenance: Not applicable, no test set was used as no performance data was provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no test set was used.
4. Adjudication method for the test set: Not applicable, no test set was used.
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, no studies were done. The 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, no performance studies were done. The device is a laser system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, no performance studies were done.
8. The sample size for the training set: Not applicable, no performance studies were done. The device is a laser system, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable, no performance studies were done and no training set for an algorithm was needed.

Regulation Number and Section

§ 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.