(143 days)
No
The summary describes a laser system with different handpieces and their technical specifications (fluence, pulse duration, etc.). There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is intended for the treatment of various medical conditions, including vascular lesions, benign pigmented lesions, and wrinkles, and also performs hair removal and permanent hair reduction, which are considered therapeutic applications.
No
The device is described as being "intended for treatment of vascular lesions", "hair removal", "treatment for Pseudofolliculitis Barbae (PFB)", "treatment of benign pigmented lesions", and "treatment of wrinkles". These are all therapeutic applications, not diagnostic ones.
No
The device description explicitly states that the device consists of two treatment handpieces that deliver laser energy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the ET LightSheer 1060 and High Speed LightSheer 1060 are laser handpieces used for treatment of various skin conditions (vascular lesions, hair removal, pigmented lesions, wrinkles). They deliver laser energy directly to the body.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to apply energy to the body's surface.
Therefore, the device's intended use and description align with a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 240
Yokneam Industrial Park
Yokneam, 2069204, ISRAEL
Tel: +972-4-9599000
Fax: +972-4-9599050 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Iman Khorshid
Director RA & QS
Tel: +972-4-9599168
Fax: +972-4-9599050
E-mail: iman.khorshid@lumenis.com |
| US Agent: | Jace R. McLane
Lumenis, Inc.
3959 South 1820 West
Salt Lake City, UT 84104
Tel: 801 6562328
Fax: 801 6562541
Email: 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 plastic
surgery 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.
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.
Indications for Use:
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.
510 (k) ET LightSheer 1060 and High Speed LightSheer 1060 Section E - Page 2 of 3
2
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.
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.
3
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.
4
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
5
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
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