ET LightSheer 1060 and High Speed LightSheer 1060 are intended for treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for hair removal, permanent hair reduction, and the treatment for Pseudofolliculitis Barbae (PFB ).

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for the treatment of benign pigmented lesions, including age spots, solar lentigines, café-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions.

ET LightSheer 1060 and High Speed LightSheer 1060 are also intended for treatment of wrinkles.

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

Device Description

The ET LightSheer 1060 and High Speed LightSheer 1060 are two treatment handpieces, intended to be used with Lumenis LightSheer Duet Laser System.

One handpiece is the ET LightSheer 1060 handpiece, which delivers laser energy through a 9 x 9 mm tip up to 90 J maximum. The settings for this handpiece are selectable pulse duration from 5 - 400 ms, selectable fluence from 10 - 100 J/cm2 and a pulse repetition rate up to 3 Hz maximum.

The second handpiece is the High Speed LightSheer 1060 handpiece, which delivers laser energy from a 22 x 35 mm diode array up to 93 J maximum. The settings for this handpiece are pulse duration from 10 - 100ms, selectable fluence from 4.5 - 12 J/cm2 and multiple pulsing up to 3 pulses.

The ET LightSheer 1060 handpiece tip is water-cooled to provide active skin cooling. The High Speed LightSheer 1060 handpiece tip uses vacuum and lower laser energy densities which reduce skin heating.

AI/ML Overview

This 510(k) summary for the Lumenis ET LightSheer 1060 and High Speed LightSheer 1060 describes the device's technical characteristics and claims substantial equivalence to predicate devices, but does not provide details of a specific clinical study with acceptance criteria and results in the way typically expected for a device proving performance against set criteria.

Instead, the submission relies on demonstrating substantial equivalence through:

Same intended use, principles of operation, and mechanism of action as previously cleared predicate devices.
Equivalent performance characteristics to predicate devices.
Identical materials and manufacturing methods to a previously cleared Lumenis device (K053628).
Conformity to established electrical and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22, and IEC 60825-1).

Therefore, I cannot populate a table of acceptance criteria and reported device performance from the provided text, nor can I answer many of the specific questions about clinical study design. There is no mention of sample sizes for test or training sets, data provenance, expert ground truth establishment, or adjudication methods for clinical performance. Similarly, no multi-reader multi-case (MRMC) or standalone algorithm performance studies are described.

The "Testing" section focuses on bench testing and compliance with safety standards, rather than clinical performance studies against specific acceptance criteria. The "Conclusion" explicitly states that the evaluation "does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device," indicating that the submission primarily leveraged the predicate device framework for clearance.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Lumenis. The logo consists of a stylized "L" inside of a circle, followed by the word "LUMENIS" in all caps. Below the logo is the tagline "Enhancing Life. Advancing Technology."

は

510(k) Summary: K133319

ET LightSheer 1060 and High Speed LightSheer 1060

Establishment Registration Number: 3004135191

Company Name:	Lumenis Ltd.6 Hakidma St.P.O.Box 240Yokneam Industrial ParkYokneam, 2069204, ISRAELTel: +972-4-9599000Fax: +972-4-9599050
Contact Name:	Iman KhorshidDirector RA & QSTel: +972-4-9599168Fax: +972-4-9599050E-mail: iman.khorshid@lumenis.com
US Agent:	Jace R. McLaneLumenis, Inc.3959 South 1820 WestSalt Lake City, UT 84104Tel: 801 6562328Fax: 801 6562541Email: Regulatory.Affair@lumenis.com
Trade Name:	ET LightSheer 1060 and High Speed LightSheer 1060
Classification name:	Powered laser surgical instrument
Regulation name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology
Common/Usual Name:	Pulse Diode Array Laser
Product Code:	GEX
Regulation No.:	878.4810
Class:	II
Panel identification:	General & Plastic Surgery

510 (k) ET LightSheer 1060 and High Speed LightSheer 1060 Section E - Page 1 of 3

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Image /page/1/Picture/1 description: The image shows the logo for Lumenis. The logo consists of a black circle with a white "L" inside, followed by the word "LUMENIS" in black, sans-serif font. Below the word "LUMENIS" is the tagline "Enhancing Life. Advancing Technology." in a smaller font size.

Predicate Devices:

LightSheer Duet Laser System from Lumenis Ltd, cleared under 510(k) K053628, the Family of Altus Medical CoolGlide Aesthetic Lasers from Altus Medical, Inc. (currently Cutera Inc.) cleared under 510(k) K022226, and the GentleMAX Family of Laser Systems from Candela Corporation cleared under 510(k) K112715.

Description of the device:

The ET LightSheer 1060 and High Speed LightSheer 1060 are two treatment handpieces, intended to be used with Lumenis LightSheer Duet Laser System.

Indications for Use:

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for hair removal, permanent hair reduction, and the treatment for Pseudofolliculitis Barbae (PFB ).

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

ET LightSheer 1060 and High Speed LightSheer 1060 are also intended for treatment of wrinkles.

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

510 (k) ET LightSheer 1060 and High Speed LightSheer 1060 Section E - Page 2 of 3

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Image /page/2/Picture/0 description: The image shows the Lumenis logo. The logo consists of a black circle with a white "L" inside, followed by the word "LUMENIS" in black, with a registered trademark symbol. Below the word "LUMENIS" is the tagline "Enhancing Life. Advancing Technology." in a smaller font.

K133319

Substantial Equivalence:

Technological Characteristics

ET LightSheer 1060 and High Speed LightSheer 1060 have the same intended use, principles of use and mechanisms of operation as Lumenis Ltd. treatment handpieces cleared under 510(k) K053628, and have equivalent performance characteristics. The materials used for ET LightSheer 1060 and High Speed LightSheer 1060, as well as the manufacturing methods, are identical to the devices cleared under 510(k) K053628. The difference resides in the wavelength of 1060nm for the proposed devices in comparison with 805nm for the cleared treatment handpieces. ET LightSheer 1060 and High Speed LightSheer 1060 have the same intended use and have equivalent performance characteristics as the Family of Altus Medical CoolGlide Aesthetic Lasers from Altus Medical, Inc. (currently Cutera Inc.) cleared under 510(k) K022226 and the GentleMAX Family of Laser Systems from Candela Corporation cleared under 510(k) K112715.

Testing

ET LightSheer 1060 and High Speed LightSheer 1060 conform to IEC 60601-1 Medical Electrical Equipment- General Requirements for Safety, IEC 60601-1-2 Medical Electrical Equipment- Electromagnetic Compatibility, IEC 60601-1-4 Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems, IEC 60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment, and IEC 60825-1 Safety of laser products - Part 1: Equipment classification, and requirements.

Conclusion:

The evaluation of the ET LightSheer 1060 and High Speed LightSheer 1060 does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20, 2014

Lumenis Ltd. Mr. Iman Khorshid Director Regulatory Affairs & Quality Specialist 6 Hakidma Street Yokneam Industrial Park P.O. Box 240 Yokneam, 2069204 ISRAEL

Re: K133319

Trade/Device Name: ET LightSheer 1060 and High Speed LightSheer 1060 Regulation Number: 21 CFR 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: February 19, 2014 Received: February 24, 2014

Dear Mr. Khorshid:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be It ind 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

Image /page/3/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is an abstract image of an eagle.

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Page 2 - Mr. Iman Khorshid

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Felipe Aguel

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133319

Device Name

ET LightSheer 1060 and High Speed LightSheer 1060

Indications for Use (Describe)

miliations to be (Dostallo)
ET LightSheer 1060 and High Speed LightSheer 1060 are intended for treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for hair removal, permanent hair reduction, and the treatment for Pseudofolliculitis Barbae (PFB ).

Permanent hair reduction is defined as the long-term, stable recuction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

0, 7, all 32 monde and High Speed LightSheer 1060 are intended for the treatment of benign pigmented lesions, including age spots, solar lentigines, cafe-au-lait spots, nevi of Ota/to, melasma, Becker's nevi and other benign pigmented lesions.

Premoment roller.

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for use on all skin types (Filzpatrick skin types I -VI), including tanned skin.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY . .

rence of Center for Devices and Radiological Health (CDRH) (Signature)

Neil R Ogden
2014.03.11 12:21:35 -04'00' For BSA

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the I he borden instructions, search existing data sources, gather and maintain the data needed and complete liftle to review firstruction. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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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.