The Silk'n is intended for removal of unwanted hair by using selective photothermal treatment. The device is generally indicated for dermatological use. The Silk'n is specifically indicated for patient removal of unwanted hair by using selective photothremal treatment under the direction of a physician, after training by a healthcare professional.

Device Description

The Silk'n hair removal system is composed of a base unit and hand held applicator.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silk'n device, structured to answer your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety	"no adverse events"
Effectiveness	"functions as intended"

Explanation: The document does not explicitly state quantitative acceptance criteria for safety or effectiveness (e.g., "efficacy rate > X%", "adverse event rate < Y%"). Instead, it provides qualitative statements about the device's performance based on the clinical study.

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

Sample Size for Test Set: Not specified. The document states "Clinical data was collected in a prospective clinical study," but no number of participants is given.
Data Provenance:
- Country of Origin: Not explicitly stated, but the submitter's address is "Apolo building, POB 533, Yokneam 20692, Israel," suggesting the study may have been conducted there or coordinated from there.
- Retrospective or Prospective: Prospective clinical study.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. (The ground truth for this device likely relates to hair reduction, which might be assessed by clinicians or through objective measurements, but the document doesn't detail this.)

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study Done: No. This type of study is not applicable to a hair removal device; it's typically used for diagnostic imaging devices where human readers interpret results.
Effect Size: Not applicable.

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

Standalone Performance Study: Not applicable. This device is a direct-use physical device, not an AI algorithm. Its performance is inherent in its operation, not in an interpretive algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly detailed. For a hair removal device, ground truth would typically be established by:
- Direct observation/measurement of hair reduction: This could involve counting hairs in a treated area, photographing the area, or using other objective measures to quantify hair growth before and after treatment.
- Patient self-assessment or clinician assessment: Subjective reports of hair reduction.
- Based on "functions as intended," it implies that the device successfully removed unwanted hair as observed or measured.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set in the conventional sense. The "training set" for device development would be engineering and optimization data, not a patient dataset for algorithm training.

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

How Ground Truth Was Established: Not applicable. (See explanation for point 8.)

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The device's safety and effectiveness were supported by a prospective clinical study. The study demonstrated that the Silk'n system functions as intended with no adverse events. The specific details regarding the number of participants, exact methodologies for assessing effectiveness (e.g., percentage of hair reduction, duration of effect), or how "no adverse events" was quantified (e.g., monitoring period, specific types of adverse events looked for) are not provided in this summary. The device also complies with specific U.S. Food and Drug Administration performance standards (21CRF § 1040.10 & 1040.11).

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTI Home SkinovationsLtd. Silk'n

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

2008

Submitter's information

Name:	Home Skinovations Ltd.
Address:	Apolo building, POB 533, Yokneam 20692, Israel
Contact:	Dr. Amir Waldman VP Regulatory Affairs

Device information

Trade/Proprietary name:	Silk'n
Common/Usual name:	Light based hair removal device
Classification name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology (21CRF §878.4810)
Product code:	GEX

Predicate devices

. ABC hair removal system, (K060839) Palomar Medical Technologies Inc.
. SpaTouch Photoepilation system, (K020856) Radiancy Ltd.

Intended use:

Device Description:

The Silk'n hair removal system is composed of a base unit and hand held applicator. Details are provided in the chapter 1: Device description, of this submission.

Performance & clinical data:

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The device complies with the following U.S. Food and Drug Administration performance standards: 21CRF § 1040.10 & 1040.11. Clinical data was collected in a prospective clinical study to support the safety and effectiveness of the Silk'n hair removal device. The clinical studies demonstrated that the Silk'n system functions as intended with no adverse events.

Substantial Equivalence:

The Silk'n system is substantial equivalent to its predicate devices. The data in this 510k submission demonstrate that the Silk'n system shares the same intended use and similar overall characteristic, therefore is substantial equivalent to its predicate devices. Details are provided in chapter 3: Substantial equivalent of this submission.

Based upon an analysis of the overall performance characteristic for the device, Home Skinovations Ltd. believes that no significant differences exit. Therefore the Silk'n should raise no new issues of safety or effectiveness.

January 11, 2008

Date

Kür Walde

Dr. Amir Waldman, VP Regulatory Affairs Home Skiovations Ltd.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.

JAN 2 3 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Home Skinovations, Ltd. % Dr. Amir Waldman VP Regulatory Affairs Apolo Building, POB 533 Yokneam 20692 Israel

Re: K072906 Trade/Device Name: Silk'n Regulatory Number: 21 CFR 878.4810 Regulatory Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 11, 2008 Received: January 17, 2008

Dear Dr. Waldman:

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

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Page 2 - Dr. Amir Waldman

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Milherson

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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510(k) Number (if known)

Device Name___________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

Mark A. Millhem

(Optional Format 1-2-96)

(Division Sign-Off) Division of General, Restorative,

and Neurological Devices

510(k) Number

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.