ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT by ESC MEDICAL SYSTEMS LTD.

The provided document is a 510(k) summary for a hair removal device. Notably, it does not explicitly state specific numerical acceptance criteria (e.g., "X% hair reduction"). Instead, the primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a previously legally marketed device.

Therefore, the acceptance criteria here are implicitly:

Demonstrating similar clinical effectiveness (hair removal) as predicate devices.
Demonstrating similar safety profile (adverse effects) as predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Effectiveness: Achieve hair removal in skin type VI patients comparable to predicate devices (IPL devices for skin types I-V).	A multi-center study was conducted to examine the clinical effectiveness of IPL™ devices in the removal of unwanted hair. The study documented the clearance rate obtained when treating skin type VI patients. The conclusion states that "IPL™ devices used to treat skin type VI patients are substantially equivalent in their level of safety and effectiveness to that obtained when using the same devices to treat patients with skin types I - V." While specific clearance rates are not quantified in this summary, the claim of substantial equivalence implies that the performance met the expected standard, based on the predicate devices.
Safety: Demonstrate a safety profile (adverse effects) comparable to predicate devices.	The study documented the adverse effects obtained when treating skin type VI patients. The conclusion states that "IPL™ devices used to treat skin type VI patients are substantially equivalent in their level of safety and effectiveness to that obtained when using the same devices to treat patients with skin types I - V." Again, specific adverse effect rates are not detailed, but the claim of substantial equivalence implies an acceptable safety profile.

Acceptance Criteria (Implicit)

Reported Device Performance

Effectiveness: Achieve hair removal in skin type VI patients comparable to predicate devices (IPL devices for skin types I-V).

A multi-center study was conducted to examine the clinical effectiveness of IPL™ devices in the removal of unwanted hair. The study documented the clearance rate obtained when treating skin type VI patients. The conclusion states that "IPL™ devices used to treat skin type VI patients are substantially equivalent in their level of safety and effectiveness to that obtained when using the same devices to treat patients with skin types I - V." While specific clearance rates are not quantified in this summary, the claim of substantial equivalence implies that the performance met the expected standard, based on the predicate devices.

Safety: Demonstrate a safety profile (adverse effects) comparable to predicate devices.

The study documented the adverse effects obtained when treating skin type VI patients. The conclusion states that "IPL™ devices used to treat skin type VI patients are substantially equivalent in their level of safety and effectiveness to that obtained when using the same devices to treat patients with skin types I - V." Again, specific adverse effect rates are not detailed, but the claim of substantial equivalence implies an acceptable safety profile.

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

Sample Size for the Test Set: Not explicitly stated. The document mentions "A multi-center study was conducted," but the number of patients included in this study ("test set") is not provided in this summary.
Data Provenance:
- Country of Origin: Not explicitly stated. Multi-center studies could involve various locations.
- Retrospective or Prospective: Not explicitly stated, but the phrasing "A multi-center study was conducted to examine..." suggests a prospective study where data was collected specifically for this purpose.

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

This information is not provided in the summary. For hair removal studies, "ground truth" often involves visual assessments by clinicians or photographic documentation, but the details of who performed these assessments and their qualifications are not included.

4. Adjudication Method for the Test Set

This information is not provided in the summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC comparative effectiveness study was not explicitly stated or implied. The study focused on the performance of the IPL device for hair removal on skin type VI patients compared to existing data/predicate devices for skin types I-V. There's no mention of human readers evaluating cases with and without AI assistance (as AI is not the primary focus here, rather it's a device).

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

Yes, in a sense, the study describes a standalone device performance. This is an Intense Pulsed Light (IPL) device, not an AI algorithm. The device operates independently to deliver treatment, and the study evaluated its clinical effect directly. There is no "human-in-the-loop" component in the context of an AI algorithm interacting with human interpretation.

7. The Type of Ground Truth Used

The ground truth for effectiveness would likely be based on:
- Clinical observation/assessment of hair clearance (reduction in hair count or density) by trained personnel.
- Adverse event reporting for safety.
- This is inferred as the study "documented the clearance rate and the adverse effects."

8. The Sample Size for the Training Set

Not applicable / not provided. This device is an IPL device, not an AI/machine learning model that typically requires a "training set." The clinical study evaluated the device's performance directly.

9. How the Ground Truth for the Training Set was established

Not applicable / not provided. As this is not an AI/ML device, there isn't a "training set" in the conventional sense that would require establishing ground truth for machine learning. The data from the multi-center study would serve as the "test set" to confirm the device's performance against the implicit acceptance criteria of substantial equivalence.

Summary

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994014

FEB 2 4 2000

510(K) PREMARKET NOTIFICATION

Hair removal for skin type VI patients
ESC Medical Systems Ltd.

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510(K) Summary

Submitter:	ESC Medical Systems Ltd.Yokneam Industrial ParkYokneam,20692, IsraelPhone: 972-4-959-9000 Fax: 972-4-959-9050
Contact:	Dr. Zvi Ladin, VP, Clinical Applications and Regulatory AffairsESC Inc.250 First AvenueNeedham, MA 02495Phone: 781-444-8446 Fax: 781-444-8812
Date summary prepared:	November 23, 1999
Device Trade Name:	IPLTM Device for hair removal
Common name:	EpiLight®; MultiLightTM
Classification name:	Laser instrument, powered, surgical (class II medical device)
Equivalent Devices:	ESC EpiLight® Hair Removal SystemESC PhotoDerm® HR
Clinical Information:	A multi-center study was conducted to examine the clinical effectiveness ofIPLTM devices in the removal of unwanted her. The study documented theclearance rate and the adverse effects obtained when treating skin type VI patientsusing an IPLTM device.
Intended Use:	Removal of unwanted hair in patients with skin type VI
Conclusion:	IPLTM devices used to treat skin type VI patients are substantially equivalent intheir level of safety and effectiveness to that obtained when using the samedevices to treat patients with skin types I - V
Additional Information:	None requested at this time

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2000

Dr. Zvi Ladin Corporate Vice President Clinical and Regulatory Affairs ESC Medical Systems Ltd. 250 First Avenue, Suite 300 Needham. Massachusetts 02494

Re: K994014 Trade Name: EpiLight and MultiLight™ Regulatory Class: II Product Code: GEX Dated: November 24, 1999 Received: November 26, 1999

Dear Dr. Ladin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Dr. Zvi Ladin

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Numill Vayen

& James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

ESC Intense Pulsed Light Systems: EpiLight® and MultiLight™

Indications For Use:

ESC Intense Pulsed Light Systems: EpiLight® and MultiLight™, are used for the removal of unwanted hair from all skin types.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)Division of General Restorative Devices
510(k) Number	K994014
Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109

(Optional Format 1-2-96)

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.