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K Number
K022583
Device Name
FLASH 1
Manufacturer
EMED, INC.
Date Cleared
2002-10-31

(87 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

This product is intended for dermatological use by physicians for the following:

  • Removal of unwanted hair in all skin types
  • Treatment of vascular and benign pigmented lesions
Device Description

The Flash 1 Intense Pulsed Light System is a microprocessor controlled system, which uses a Xenon lamp that delivers a wavelength of 590 nanometers. The four principal parts of the system include the capacitor charge system, the electronic control system, the handpiece with lamp box and the control panel.

AI/ML Overview

This submission for the Flash 1 device does not include performance data or a study proving that the device meets acceptance criteria.

The 510(k) summary explicitly states: "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."

Therefore, I cannot provide the requested information from the provided text, as the document states that such data was not submitted.

Here's why each of your requested points cannot be answered based on the provided text:

  1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are provided.
  2. Sample sized used for the test set and the data provenance: No test set or data from a study is provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment or expert involvement for a test set is mentioned.
  4. Adjudication method for the test set: No test set or adjudication method is described.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study is mentioned, and the device is an Intense Pulsed Light System, not an AI diagnostic tool for image reading.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone performance study is mentioned for this hardware device.
  7. The type of ground truth used: No ground truth is discussed as no performance study was conducted.
  8. The sample size for the training set: No training set is mentioned as no performance study was conducted.
  9. How the ground truth for the training set was established: No ground truth for a training set is mentioned.

The submission relies on a "database search" for adverse effects of currently marketed pulsed light systems as part of its safety and effectiveness evaluation, not on new performance data for the Flash 1 specifically.

§ 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.