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K Number
K992814
Device Name
CYNOSURE ACCOLADE LASER
Manufacturer
CYNOSURE, INC.
Date Cleared
1999-09-15

(26 days)

Product Code
GEX
Regulation Number
878.4810
Type
Special
Panel
SU
Reference & Predicate Devices
K990977
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Cynosure Accolade Laser is indicated for tattoo and benign cutaneous pigmented lesions removal.

Device Description

The Accolade Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench.

AI/ML Overview

The provided document is a 510(k) summary for the Cynosure Accolade Laser, which is a medical laser system. The document explicitly states:

Nonclinical Performance Data: None
Clinical Performance Data: None

This means that no studies or data were provided to demonstrate the device meets any acceptance criteria for performance, whether nonclinical or clinical. The FDA approval was based on substantial equivalence to a predicate device (Cynosure PhotoGenica HT10 Laser) in terms of treatment wavelength, pulse duration, pulse energy, and biological effects, not on new performance data from the Accolade Laser itself.

Therefore, I cannot provide the requested information. The document does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for a test set or data provenance.
  3. Number of experts or their qualifications for establishing ground truth.
  4. Adjudication method.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Information about a standalone performance study.
  7. The type of ground truth used.
  8. The sample size for the training set.
  9. How the ground truth for the training set was established.

§ 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.