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K Number
K060567
Device Name
SPECTRAGENICS ATS-1
Manufacturer
SPECTRAGENICS, INC.
Date Cleared
2006-04-28

(56 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
K013623,K030338,K030883,K040081,K041086,K051268,K032205
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SpectraGenics ATS-1 is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

Device Description

The SpectraGenics ATS-1 is a handheld, electrically-powered light therapy device that produces light at a wavelength of nominally 410 nm.

AI/ML Overview

The provided text (K060567) is a 510(k) summary for the SpectraGenics ATS-1, a light therapy device for moderate inflammatory acne vulgaris. However, it does not contain any information regarding acceptance criteria, device performance, or details of a clinical study.

The document primarily focuses on:

  • The administrative details of the 510(k) submission (applicant, contact, date, device name, classification, predicate devices).
  • A brief description of the device and its intended use.
  • A statement that "Clinical data is provided to demonstrate the safety and efficacy of the SpectraGenics ATS-1."
  • The FDA's letter of clearance, confirming substantial equivalence to predicate devices, but no specifics about the clinical data itself.
  • The "Indications for Use" statement.

Therefore, I cannot provide the requested information. The document merely states that clinical data was provided, but does not summarize or present that data, nor does it detail acceptance criteria or the specifics of a study.

To answer your request, I would need a different document that actually describes the clinical study performed for the SpectraGenics ATS-1, including its methodology, results, and acceptance criteria.

§ 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.