POWERLITE 600 EP SYSTEM

• K Number: K030423
• Device Name: POWERLITE 600 EP SYSTEM
• Manufacturer: PRESWEDE AB
• Date Cleared: 2003-05-09 ( 88 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Powerlite 600® EP System is used for the removal of unwanted hair.

Device Description

The Powerlite 600® EP System delivers pulsed light at a wavelength beginning at a wavelength of 600nm. The device consists of three interconnected sections: the system console which houses the internal cooling system, power supply and micro-controller, the handle hose to the handpiece, and the handpiece, which houses the wavequide.

AI/ML Overview

The provided text is a 510(k) summary for the Powerlite 600® EP System. It does not contain details about acceptance criteria, device performance, clinical studies showing the device meets acceptance criteria, or ground truth establishment.

The document explicitly states:

• "8. Discussion of Clinical Tests Performed: Non-Applicable"

This indicates that the submission did not rely on clinical trials to demonstrate substantial equivalence. Instead, it focused on the device's technical similarity and intended use compared to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth from the provided text. The document's purpose is to establish substantial equivalence based on non-clinical aspects and comparison to a predicate device, not to report on clinical performance against specific acceptance criteria.

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.