The Depilite EL-8b DERMO FLASH TM Model A system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction.
The Depilite EL-8b DERMO FLASH TM Model SX-513a system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction.
The Depilite EL-8b DERMO FLASH TM Model SX-513c system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne.
The Depilite EL-8b DERMO FLASH TM Model C system is a microprocessor-controlled dual nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne.

Device Description

The Depilite EL-8b Series DERMO FLASH™ devices are microprocessorcontrolled nonablative light-based medical devices which use pulsed xenon lamps to deliver a selectable range of polychromatic light outside the range of harmful ultraviolet wavelengths leaving only the visual and infrared light to be presented for photo thermolysis epilation and skin treatments. Pre-set and manual delivery parameters - such as the appropriate wavelength, energy, pulse rate and exposure time - and other system features are modulated from the display and control panel on the main unit. The corresponding fluence is delivered through an air-cooled double lamp hand piece without making contact with the treated area (Non Contact Pulsed Light or NCPL™). The complete system consists of the Depilite EL-8b DERMO FLASH™ machine, a photothermolysis handle with treatment head, keys for main switch, a foot switch, electric power cable, protective goggles, and instruction manual.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) documentation does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics from a clinical study. The submission instead focuses on demonstrating substantial equivalence to predicate devices for specific "Indications for Use."

The "performance" is implicitly deemed acceptable if the device is found substantially equivalent to predicate devices already on the market with established safety and efficacy for the stated indications.

Implicit Acceptance Criteria (based on "Indications for Use" and substantial equivalence):

Acceptance Criteria Category	Specific Criteria (Implicit)	Reported Device Performance (Implicit via Substantial Equivalence to Predicate Devices)
Intended Use	The device should be safe and effective for: - Permanent hair reduction - Treatment of vascular lesions - Treatment of benign pigmented lesions - Treatment of inflammatory acne (Applicable models vary as per specific Indications for Use statements)	The Depilite EL-8b Series DERMO FLASH™ Systems are "substantially equivalent to other legally-marketed flash light-based medical devices in U.S. commercial distribution for the same dermatological applications." This implies similar performance to predicates for these indications.
Safety	The device should be non-ablative, use polychromatic light outside harmful UV wavelengths, and comply with mandatory special controls (21 C.F.R. Part 1040 – Performance Standards for Light-Emitting Products). The differences in specifications from predicate devices should not raise new questions of safety.	The device is described as "microprocessor-controlled nonablative light-based medical devices which use pulsed xenon lamps to deliver a selectable range of polychromatic light outside the range of harmful ultraviolet wavelengths." It also states compliance with 21 C.F.R. Part 1040.
Efficacy	The device should achieve the intended clinical effects for permanent hair reduction, and treatment of vascular/benign pigmented lesions and inflammatory acne. The differences in specifications from predicate devices should not result in different performances or raise new questions of efficacy.	Substantial equivalence to predicate devices is the sole basis for efficacy. The document does not provide direct efficacy data for the device itself.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not describe a specific clinical study with a "test set" for the Depilite EL-8b Series DERMO FLASH™ Systems. The basis for clearance is Substantial Equivalence to predicate devices. Therefore, there is no sample size or data provenance provided for a test set of this specific device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

As no specific test set clinical study for the Depilite EL-8b Series DERMO FLASH™ Systems is described, there is no information provided on the number or qualifications of experts used to establish ground truth.

4. Adjudication Method for the Test Set

Since no specific test set clinical study is described, there is no adjudication method provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned or described in the provided documentation. The clearance is based on substantial equivalence to existing devices, not a direct comparison of human readers with significant AI assistance. The device is a direct treatment device, not an AI diagnostic aid for human readers.

6. Standalone Performance Study

The 510(k) submission does not describe a standalone performance study (i.e., algorithm only without human-in-the-loop) for the Depilite EL-8b Series DERMO FLASH™ Systems. This device is a direct energy delivery system, not a diagnostic or AI algorithm in the traditional sense that would have "standalone performance" in terms of accuracy metrics. Its performance is tied to its physical output and clinical effect.

7. Type of Ground Truth Used

The documentation does not specify a type of ground truth used for evaluating the Depilite EL-8b Series DERMO FLASH™ Systems, as it relies on substantial equivalence. For the predicate devices, it would have been clinical outcomes (e.g., hair reduction, lesion clearance) established through clinical trials.

8. Sample Size for the Training Set

The provided documentation does not describe any "training set" as this is a physical medical device and not an AI/machine learning algorithm requiring a training phase in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

As there is no described training set, there is no information on how ground truth for a training set was established.

Summary of Approach:

This 510(k) clearance for the Depilite EL-8b Series DERMO FLASH™ Systems relies entirely on the concept of Substantial Equivalence. This means the manufacturer demonstrated to the FDA that their device is as safe and effective as a legally marketed predicate device(s) that already exist on the market. They achieve this by comparing the technological characteristics, intended use, and indications for use of their device to those of the predicate devices. They then argue that any differences do not raise new questions of safety or efficacy. Therefore, the detailed clinical study data, acceptance criteria, and ground truth methodologies associated with this specific device are not presented as they typically would be for a novel device or a device undergoing a PMA. Instead, the "proof" is the established safety and efficacy of the predicate devices.

Summary

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510(k) Number K052371

MAY - 4 2006

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

510(k) Summary Statement for MED-OP Aesthetic Technologies, Ltd. Depilite EL-8b Series DERMO FLASH™ Systems

Regulatory Authority:

Safe Medical Devices Act of 1990, Title 21 C.F.R. Section 807.92

Submitter's Name:

Hair International Systems USA, Inc. 11526 Sorrento Valley Road, Suite IB San Diego, California 92121 Tel: (858) 755-5758 Fax: (858) 755-5574

Contact Person:

Amnon Zakay, President and CEO

Name of Devices:

Depilite EL-8b Series DERMO FLASH™ Systems (and Delivery Accessories):

DERMO FLASH™ Model A .
. DERMO FLASH™ Model SX-513 A
. DERMO FLASH™ Model SX-513 C
. DERMO FLASH™ Model C

Common Names:

Dermatology Flash Lamp Systems

Section II - Page 1 of 3

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2371

510(K) PREMARKET NOTIFICATION Depilite EL-8b Series DERMO FLASH™ Systems MED-OP Aesthetic Technologies, Ltd. March 20, 2006

Classification:

Laser surgical instrument for use in general and plastic surgery and in dermatology. Title 21 C.F.R. Section 878.4810

Medical Specialty - General & Plastic Surgery

Device Class II - Special Controls

Product Code - GEX

Panel - 79

Equivalent Devices:

Light-Emitting Source: Flash Lamp Intense Pulsed Light (IPL) Technology:

. Clareon™ Pulsed Light System Solarus™ Pulsed Light System Novalis Medical, LLC K043319, Dec. 17, 2004
. ProLite / Plasmalite MPX Pulsed Light System Medical Bio Care Nordic AB K023081, Dec. 16, 2002
Flash 1 . emed, Inc. K022583, Oct. 31, 2002
. EpiLight® PhotoDerm® HR ESC Medical Systems, Ltd. K991935, January 27, 2000

Section II - Page 2 of 3

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f 2371

510(K) PREMARKET NOTIFICATION Depilite EL-8b Series DERMO FLASH™ Systems MED-OP Aesthetic Technologies, Ltd. March 20, 2006

Description of the DERMO FLASH™ Series Devices:

The Depilite EL-8b Series DERMO FLASH™ devices are in compliance with mandatory special controls as required by 21 C.F.R. Part 1040 – Performance Standards for Light-Emitting Products.

Indications for Use:

The Depilite EL-8b Series DERMO FLASH™ Systems are microprocessorcontrolled nonablative light-based medical devices designed for permanent hair reduction, and the treatment of vascular and benign pigmented lesions and inflammatory acne, on skin types I-IV.

Substantial Equivalency:

The differences in specifications of the Depilite EL-8b Series DERMO FLASH™ devices and the predicate device(s) do not result in different performances or raise new questions of safety or efficacy.

Conclusion:

The Depilite EL-8b Series DERMO FLASH™ Systems are substantially equivalent to other legally-marketed flash light-based medical devices in U.S. commercial distribution for the same dermatological applications.

Section II - Page 3 of 3

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2006

Hair International Systems USA, Inc. c/o Horton, Whiteley & Cooper Mr. Craig A. Mitchell 4590 Macarther Boulevard - Suite 500 15770 Laguna Canyon Road Newport Beach, California 92692

Re: K052371 Trade/Device Name: Depilite EL-8B Series DERMO FLASH™ System DERMO FLASH" Model A M DERMO FLASH' Model SX-513 A DERMO FLASH™ Model SX-513 C DERMO FLASH™ Model C Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: April 21, 2006 Received: April 25, 2006

Dear Mr. Mitchell:

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, J rug, 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.

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Page 2 - Mr. Craig A. Mitchell

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 maution wour not not incant or any Federal statutes and regulations administered by other Federal agencies. You must CED Dec 20T 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 1000-1000. 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), please contact the Office of Compliance at (240) 276-0115. Also, please note (21 cr regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ohtain other general information on your responsibilities under the Act from the Division of Stoull 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,

Hukukemena

Mark N. Melkerson 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

510(k) Number (if known):	510(k) Number K052371
Device Name:	Depilite EL-8b Series DERMO FLASH TM Systems
Indications For Use:	The Depilite EL-8b DERMO FLASH TM Model A system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction.
	The Depilite EL-8b DERMO FLASH TM Model SX-513a system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction.
	The Depilite EL-8b DERMO FLASH TM Model SX-513c system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne.

Prescription Use __ X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Humphrey

(Division Sign-Off) (Division of General, Restorative,
Division of General, Restorative, Page 1 of _1 and Neurological Devices

Number K052371

Caller Baker Sa

1. 1

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Indications for Use

510(k) Number (if known):

510(k) Number K052371

Device Name: Depilite EL-8b DERMO FLASH™ Systems

Indications For Use:

And The France of the comments of

The Depilite EL-8b DERMO FLASH™ Model C system is a microprocessor-controlled dual nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne.

Page 2 of 2

and the same of the status and the season the season

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.