MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE

• K Number: K963340
• Device Name: MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE
• Manufacturer: CONTINUUM BIOMEDICAL, INC.
• Date Cleared: 1997-05-12 ( 259 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K955131 , K952636 , K940607 , K940636 , K922935 , K922577 , K915497

Intended Use

For use in dermatology for the removal of tattoos and the treatment of vascular and pigmented lesions.

Device Description

The new Dye Accessory Handpiece for the Medlite™ Nd:YAG Laser System is consists of four primary parts: the handpiece which contains a short optical cavity and focusing optics, the plastic dye module, the commercial power meter and appropriate laser safety goggles.

AI/ML Overview

This 510(k) summary, K963340, does not contain information related to software, artificial intelligence, or diagnostic device performance. The device described, the "Medlite™ Nd:YAG Laser System: New Dye Accessory Handpiece," is a dermatology laser system.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria: The document does not define any specific performance acceptance criteria for the device in terms of diagnostic accuracy, sensitivity, specificity, or similar metrics. Its "Comparison" section focuses on delivering "slightly altered wavelengths for increased efficiency."
• No Device Performance Metrics: There are no reported device performance metrics like accuracy, AUC, sensitivity, specificity, etc., because the device is a therapeutic laser, not a diagnostic one.
• No Clinical Study Data: The sections "Nonclinical Performance Data" and "Clinical Performance Data" both explicitly state "none." This means no studies were performed to prove performance against specific criteria, clinical or otherwise.
• No Test Set/Ground Truth: Since no clinical or performance studies were conducted or reported, there's no mention of a test set, its provenance, the number of experts, adjudication methods, or the type of ground truth used.
• No MRMC or Standalone Study: These types of studies relate to diagnostic devices, particularly those involving AI or human interpretation. This laser system does not fall into that category.
• No Training Set: As there's no AI component or diagnostic algorithm, there's no mention of a training set or how ground truth for a training set would be established.

Therefore, I cannot populate the table or answer the questions as they pertain to aspects that are not relevant or present in this 510(k) summary for a therapeutic laser system.

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.