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K Number
K111454
Device Name
ILUMINAGE DIODE LASER
Manufacturer
CYNOSURE, INC.
Date Cleared
2012-07-05

(407 days)

Product Code
OHS,GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
K111454
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Iluminage laser device is indicated for use in the treatment of periorbital and perioral wrinkles.

Device Description

Iluminage is a diode laser composed of a handpiece, base unit and a charger unit.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the Iluminage Diode Laser, primarily focusing on its substantial equivalence to a predicate device for marketing approval.

Specifically, the document states:

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

This means that no performance studies, clinical or non-clinical, were submitted or discussed in this particular document to establish acceptance criteria or demonstrate device performance against such criteria. The approval is based on the device having the "same indications for use, the same principle of operation, the same wavelength and the same technology as the predicate devices."

Therefore, I cannot provide the requested information:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample sized used for the test set and the data provenance.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
  4. Adjudication method for the test set.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
  6. If a standalone performance study was done.
  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.