The Dealight Intense Pulsed Light (IPL) is indicated for use in surgical applications requiring selective photohermolysis (photocoagulation or coagulation) and hemostasis of soft tisse in the medical specialties of general and plastic surgery, and dermatology. Intense Pulsed Light Energy/Wavelengths (590-1200 nm) are indicated for: The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent1, hair reduction in skin types I-V through selective targeting of melanin in hair follicles. 1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.

Device Description

The Dealight Intense Pulsed Light (IPL) is comprised of the following main components: - A light / laser system console (including software and control electronics) - A control and display panel - Air cooling system - A hand-piece with cut off filters -

AI/ML Overview

The provided text is a 510(k) summary for the Dealight IPL device, which is an Intense Pulsed Light system. It details the product description, intended use, and the rationale for substantial equivalence to a predicate device. However, it does not contain the specific information required to complete the requested table and answer the study-related questions.

The 510(k) summary is a premarket notification to the FDA, demonstrating that the device is at least as safe and effective as a legally marketed predicate device. It typically focuses on comparing technical specifications, operating performance, and intended uses rather than presenting new clinical study data with detailed acceptance criteria and performance metrics in the way a clinical trial report would.

Therefore, most of the information requested in your prompt is not available in the provided document.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in document. Typically, for a device like IPL, acceptance criteria would involve specific percentages of hair reduction, safety endpoints (e.g., adverse events below a certain threshold), or treatment efficacy metrics (e.g., clearance rates for pigmentation).	The document states the device is indicated for "stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles." It also refers to the definition of "Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen." However, no quantitative performance metrics (e.g., 70% hair reduction at 6 months) are provided.

Acceptance Criteria

Reported Device Performance

Not specified in document. Typically, for a device like IPL, acceptance criteria would involve specific percentages of hair reduction, safety endpoints (e.g., adverse events below a certain threshold), or treatment efficacy metrics (e.g., clearance rates for pigmentation).

The document states the device is indicated for "stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles." It also refers to the definition of "Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen." However, no quantitative performance metrics (e.g., 70% hair reduction at 6 months) are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not available. The document does not describe a new clinical study with a test set. The claim of substantial equivalence is made against a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not available. No new test set data or expert-established ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not available. No new test set data 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. This device is an IPL system for hair removal/dermatological applications, not an AI-assisted diagnostic device that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a hardware-based medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable/Not available. No new clinical study data with ground truth is described. The device's safety and effectiveness are established by demonstrating substantial equivalence to a predicate device, which implies the predicate device had established its ground truth in previous studies.

8. The sample size for the training set:

Not applicable/Not available. This is a hardware device, not an AI algorithm requiring a training set in the conventional sense.

9. How the ground truth for the training set was established:

Not applicable/Not available. See point 8.

Summary of available information from the document:

Rationale for Substantial Equivalence: The Dealight is deemed substantially equivalent to "Lumenis's/ESC Family of IPL' systems (K030342)" based on comparable technical specifications, operating performance features, general physical configuration, and intended uses.
Safety and Effectiveness Information: The device conforms with federal regulations and performance standards 21 CFR 1040.10 and 21 CFR 1040.11 for medical laser systems.

In essence, the provided 510(k) summary focuses on regulatory compliance and equivalence to an already approved device rather than a detailed presentation of a newly conducted clinical study with specific acceptance criteria and detailed performance data.

Summary

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K043032

510 (k) Summary

Oct. 18, 2004	Greg Kennebeck – ContactEuropro, Inc.3952 Camino Ranchero Rd.Camarillo, CA 93012Phone: 800-272-1716Fax: 805-482-9099
Proprietary Name:	Dealight IPL
Common Name:	Laser Powered Surgical Instrument
Regulation #:	878.4810
Regulatory Status:	Class II
Product Code:	GEX

PRODUCT DESCRIPTION

The Dealight Intense Pulsed Light (IPL) is comprised of the following main components:

A light / laser system console (including software and control electronics) -
A control and display panel -
Air cooling system -
A hand-piece with cut off filters -

INTENDED USE

Intense Pulsed Light Energy/Wavelengths (590-1200 nm) are indicated for:

The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent1, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.

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K04 3032

Rationale for Substantial Equivalence

The Dealight is substantial equivalent to Lumenis's/ESC Family of IPL' systems (K030342). The Dealight is comparable to the predicate device in terms of the technical specifications, operating performance features, general physical configuration and intended uses.

Safety and Effectiveness Information

The Dealight conforms with federal regulations and performance standards 21 CFR 1040.10 and 21 CFR 1040.11 for medical laser systems.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2005

Mr. Greg Kennebeck Europro, Inc. 3952 Camino Ranchero Road Camarillo, California 93012

Re: K043032 Trade/Device Name: Dealight IPL Regulation Number: 21 CFR 878.4810 Regulation Name: 21 Crise of 21 Crise of 2018 - 12:00
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 10, 2005 Received: June 14, 2005

Dear Mr. Kennebeck:

We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your becaon 910(tr) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the clerosuly to regally manage of the Medical Device American of the Federal Food. Days commerce provision to May 20, 1978, the exactions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, ulciclefore, market the device, books of the more of registration, listing of general controls provisions of the fiel 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 If your device is classinod (600 above) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to suell additions, 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 Flease be advised that I Dri 3 issualled or our device complies with other requirements of the Act that I DA has made a doternations administered by other Federal agencies. You must of any it catal statutes and regulations and and limited to: registration and listing (21 Comply will an the 71et 51equirements)01); good manufacturing practice requirements as set CITY art 807), adeimig (21 CFR Part 820), and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Greg Kennebeck

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailtoning of substantial equivalence of your device to a legally premarket notification: "The PPF intelligention 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), please If you desire specific advice for Jour as 10 1) 276-01 15. Also, please note the regulation entitled, Conlect the Office of Compunation at (21 t 7 = 1 = = = 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small biller general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers; International and Oction: http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

to-lit

Miriam C. Provost, Ph.D. Acting 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

K043032 510 (k) Number: Dealight IPL Device Name:

· · · · · · .

Intense Pulsed Light Energy/Wavelengths (590-1200 nm) are indicated for:

The removal of unwanted hair from all skin types, and to effect stable long-term, -The removed of an wadestion in skin types I-V through selective targeting of melanin in hair follicles.
Prescription Use 2 (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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of Of General, Restorative Nemolorical Devic

K043032

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.