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K Number
K053608
Device Name
CYNOSURE PHOTOGENICA V-STAR LASER
Manufacturer
CYNOSURE, INC.
Date Cleared
2006-02-13

(48 days)

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

General Surgery: Photocoagulation of benign cutaneous vascular and vascular dependent lesions and benign cutaneous lesions.

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangioma, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis and the treatment of wrinkles. Treatment of Benign Epidermal Pigmented Lesions. Treatment of Inflammatory Acne Vulgaris

Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.

Podiatry: Treatment of benign cutaneous lesions, such as warts.

Device Description

The Cynosure PhotoGenica V-Star laser is a pulse dye laser, having an organic dye as a lasing medium.

Laser activation is by footswitch or finger switch. Overall weight of the laser is 285lbs, and the size is 44×19"×24" (HxWxD).

Electrical requirement is 220 VAC. 30A. 50-60 Hz. single phase.

AI/ML Overview

The provided document is a 510(k) summary for the Cynosure PhotoGenica V-Star Laser. It explicitly states:

  • Nonclinical Performance Data: none
  • Clinical Performance Data: none

Therefore, based on the provided information, there is no acceptance criteria or study data described to demonstrate the device meets any specific performance criteria. The device's clearance is based on substantial equivalence to a predicate device (Cynosure PhotoGenica VLS-Star Laser), not on new performance data.

Since no performance study was conducted or presented in this 510(k) summary, the following points cannot be addressed:

  1. Table of acceptance criteria and reported device performance: Not applicable.
  2. Sample size used for the test set and data provenance: Not applicable.
  3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
  6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
  7. Type of ground truth used: Not applicable.
  8. Sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

§ 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.