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:

A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are provided.
Sample sized used for the test set and the data provenance: No test set or data from a study is provided.
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.
Adjudication method for the test set: No test set or adjudication method is described.
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.
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.
The type of ground truth used: No ground truth is discussed as no performance study was conducted.
The sample size for the training set: No training set is mentioned as no performance study was conducted.
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.

Summary

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OCT 31 2002

510(k) SUMMARY

KO22583

Applicant: emed, Inc. 191 West Wilbur Road, Suite 103, Thousand Oaks, Address: CA 91350 2. Contact Persons: Cornelia Damsky Tel: (203) 323-7535 Kenneth Karasiuk Tel: (805)-446-2200 Ext 14 July 29, 2002 3. Preparation Date: 4. Device Submitted: Flash 1 and accessories 5. Proprietary Name: Flash 1 6. Common Name: Intense Pulsed Light System 7. Classification Name: Laser surgical instrument for use in General and Plastic Surgery and in Dermatology. Product Code GEX, Panel 79 8. Predicate Device: The Flash 1 is substantially equivalent to the following currently marketed devices: Palomar's EsteLux, Medical Bio Care's ProLite Pulsed Light Systems, Radiancy's Spa Touch and ESC Medical System's IPL Quantum SR. 9. 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. 10. Intended Use: The Flash 1 is intended for dematological use by a physician for treatment of vascular and benign pigmented lesions and removal of unwanted hair in all skin types. 11. Performance Data: No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). A data base search has been performed to evaluate any adverse effects of the device that is currently marketed. No data submitted for section 807.92

6[(b)(1)(2)(3c)].

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SUMMARY:

Beginning with the year, 1966, to the present, a database search was completed for adverse safety and effectiveness reported with use of a pulsed light system for hair removal, treatment of vascular and benign pigmented lesions.. The results of the database search are located in Appendix G.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

emed. Inc.

Ms. Cornelia Damsky . 191 West Wilbur Road, Suite 103 Thousand Oaks, California 91360

OCT 31 2002

Re: K022583

Trade/Device Name: Flash 1 Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: July 29, 2002 Received: August 5, 2002

Dear Ms. Damsky:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Cornelia Damsky

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Muriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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INDICATIONS FOR USE

Flash 1

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 트
Miriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K022583

Regulation Number and Section

§ 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.