QUADROSTAR 532

• K Number: K060457
• Device Name: QUADROSTAR 532
• Manufacturer: ASCLEPION LASER TECHNOLOGIES GMBH
• Date Cleared: 2006-03-20 ( 26 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Special
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

The QuadroStar 532 is intended for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue.

Device Description

The QuadroStar 532 Laser System is a frequency doubled diode - pumped solid state laser (LBO) . It consists a laser enclosure and optic delivery system (fiber bundle and handpiece).

AI/ML Overview

The provided text is a 510(k) summary for a laser system (QuadroStar 532). It explicitly states:

• "Nonclinical Performance Data: None"
• "Clinical Performance Data: None"

This indicates that no clinical or nonclinical studies were performed to prove the device meets acceptance criteria. The submission relies on substantial equivalence to a predicate device (BeautyStar 532 Laser System) based on similar principles of operation, wavelength, and power range for the same indications for use.

Therefore, the following information cannot be extracted from the provided text, as no such studies were conducted or reported:

1. Table of acceptance criteria and reported device performance: Not applicable as no performance data is presented.
2. Sample size used for the test set and data provenance: No test set information available.
3. Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth established from experts for a test set.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was done.
6. Standalone (algorithm only) performance study: Not applicable as this is a physical laser device, not an algorithm.
7. Type of ground truth used: Not applicable as no studies were performed.
8. Sample size for the training set: Not applicable as no training set was used (e.g., for an AI/ML device).
9. How the ground truth for the training set was established: Not applicable.

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.