LogoFDA 510(k) Search
K Number
K965128
Device Name
CYNOSURE PHOTOGENICA VLV CUTANEOUS VASCULAR LESION LASER
Manufacturer
CYNOSURE, INC.
Date Cleared
1997-07-14

(203 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PhotoGenica YLV laser is used for the treatment of benign cutaneous vascular and vascular dependent lesions.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a clearance letter from the FDA for a device called "Cynosure PhotoGenica VLV Cutaneous Vascular Lesion Laser," indicating that it has been determined to be substantially equivalent to devices marketed prior to May 28, 1976.

The letter mentions:

  • Trade Name: Cynosure PhotoGenica VLV Cutaneous Vascular Lesion Laser
  • Regulatory Class: II
  • Product Code: GEX
  • Indications For Use: The PhotoGenica YLV laser is used for the treatment of benign cutaneous vascular and vascular dependent lesions.

However, it does not include details on:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number of experts used to establish ground truth or their qualifications.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study or effect size.
  6. Standalone performance study.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document serves as an FDA clearance notification rather than a detailed technical report or study summary.

§ 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.