(28 days)
Not Found
No
The description focuses on the laser technology, handpieces, and safety features. There is no mention of AI, ML, or any data processing that would suggest the use of such technologies.
Yes.
The device is used for the treatment of vascular lesions and Pseudofolliculitis Barbae (PFB), which are therapeutic applications. Additionally, the performance studies mention "therapeutic laser equipment."
No
The device description and intended use clearly state that the LightSheer Desire Light Laser System is an aesthetic laser system used for various treatments (e.g., hair removal, vascular lesions, pigmented lesions) by delivering pulsed infrared laser light. There is no mention of it being used to diagnose conditions or process diagnostic images. Even though EN 60601-2-22 is mentioned, which refers to "therapeutic and diagnostic laser equipment," the overall context of the device's function, as described, is purely therapeutic/treatment-oriented, not diagnostic.
No
The device description clearly outlines a physical laser system with a console, handpieces, and associated hardware components for delivering laser energy and cooling. While software is mentioned for verification and validation, the core of the device is hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical, aesthetic, and cosmetic applications" and for "treatment of vascular lesions," "treatment of Pseudofolliculitis Barbae (PFB)," "hair removal," "permanent hair reduction," "treatment of benign pigmented lesions and leg veins." These are all therapeutic or aesthetic procedures performed directly on the patient's body.
- Device Description: The description details a laser system that delivers pulsed infrared laser light to the treatment area on the patient's skin.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a therapeutic laser system used for direct treatment of conditions on the patient's body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The LightSheer pulsed diode array laser systems are indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer pulsed diode array laser systems are intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, the treatment of Pseudofolliculitis Barbae (PFB). The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is also indicated for hair removal, permanent hair reduction* and the treatment of benign pigmented lesions and leg veins.
- Note: 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The modified LightSheer Desire Light Laser System is a non-invasive aesthetic laser system that delivers pulsed infrared laser light with a wavelength ranging from 790-830 nm (805 nm nominal). The system consists of a laser console and two optional handpieces, ET or XC, which can be connected to the console, one at a time, via a universal plug-in connector and an umbilical cable.
The ET handpiece; delivers laser energy through a 9mm tip up to 81 J maximum. The settings for this handpiece are selectable pulse duration from 5-400 ms, selectable fluency from 10-100 J/cm² and a pulse repetition rate up to 3 Hz maximum. The XC handpiece; delivers laser energy through a 12mm x 12mm tip up to 58 J maximum. The settings for this handpiece are selectable pulse duration from 5-400 ms, selectable fluency from 10-40 J/cm² and a pulse repetition rate up to 3 Hz maximum
The laser system delivers pulsed infrared laser light from the diode array in the ET or XC handpiece to the treatment area. In standard use, the handpiece is pressed against the patient's skin and a pulse of light is delivered. To initiate energy output, the system requires redundant activation of the handpiece enable button and the handpiece trigger button while the system is in the Ready mode.
The ET and XC handpieces include a chilled sapphire tip that is water-cooled to provide active skin cooling. The physician is able to control the settings of laser energy from the LCD display on the main console.
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)
Performance testing was conducted in order to demonstrate the performance of the LightSheer Desire Light Laser System and its substantial equivalence, with respect to the safety and effectiveness, to the cleared predicate system. The following activities were performed:
- Risk analysis activities in compliance with the requirements of ISO 14971.
- . Electrical and laser safety and electromagnetic compatibility testing as required to conform to with the following performance standards:
- । EN 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- requirements and tests.
- EN 60601-1: Medical electrical equipment Part 1: General requirements for । basic safety and essential performance.
- EN 60601-2-22: Medical electrical equipment- part 2: particular requirements for । the safety of diagnostic and therapeutic laser equipment.
- । EN 60825-1: Safety of laser products-Part 1: Equipment classification and requirements.
- Software verification and validation testing.
- . Environmental testing demonstrating the ability of the subject system to withstand variant operation, storage and transportation conditions.
- . System testing (e.g. handpieces use and authorization, treatment parameters, energy measurements, handpiece replacement, handpiece cooling, safety controls).
Test results indicated that the subject LightSheer Desire Light Laser System performs in accordance with its requirements and specifications, in similarity to its predicate device. Consequently, the LightSheer Desire Light Laser System was found to perform as well as its predicate, to be as safe and effective for its intended use as its predicate, and is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
LightSheer Duet Laser System, cleared under K053628.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2015
Lumenis Ltd. Ms. Elissa Burg Director of Regulatory Affairs & Quality Systems Yokneam Industrial Park Yokneam 2069204, Israel
Re: K151947
Trade/Device Name: LightSheer Desire Light Laser System 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: July 12, 2015 Received: July 15, 2015
Dear Ms. Burg:
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 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
1
CFR Part 807); labeling (21 CFR [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809]); medical device 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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number ( if known ) | K151947 |
|---|---|
| Device Name | LightSheer Desire Light Laser System |
Indications for Use (Describe)
The LightSheer pulsed diode array laser systems are indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer pulsed diode array laser systems are intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, the treatment of Pseudofolliculitis Barbae (PFB). The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is also indicated for hair removal, permanent hair reduction* and the treatment of benign pigmented lesions and leg veins.
- Note: 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
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510(K) SUMMARY
Image /page/3/Picture/1 description: The image shows the Lumenis logo. The logo consists of a blue letter "L" inside of a blue circle on the left, followed by the word "Lumenis" in blue. Below the word "Lumenis" is the phrase "Energy to Healthcare" in a smaller blue font.
LightSheer Desire Light Laser System
| Applicant Name: | Lumenis Ltd.
6 Hakidma Street PO Box 240
Yokneam Industrial Park,
Yokneam 2069204, Israel
Tel: +972-4-9599000
Fax: +972-4-9599046 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Elissa Burg - Director of Regulatory Affairs & Quality Systems
Lumenis Ltd. |
| | 6 Hakidma Street PO Box 240
Yokneam Industrial Park,
Yokneam 2069204, Israel
Tel: +972-4-9599168
Fax: +972-4-9599198
Mail: Elissa.Burg@lumenis.com |
| Date Prepared: | August 09, 2015 |
| Trade Name: | LightSheer Desire Light Laser System |
| Common Name: | Pulsed Diode Array Laser |
| Classification Name: | Powered laser surgical instrument |
| Product Code: | GEX |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 878.4810 |
| Panel: | General & Plastic Surgery |
| Predicate Device: | LightSheer Duet Laser System, cleared under K053628. |
Special 510(k) LightSheer Desire Light Laser System
4
Intended Use/ Indications for Use:
The LightSheer pulsed diode array laser systems are indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer pulsed diode array laser systems are intended for use on all skin types (Fitzpatrick skin types I – VI), including tanned skin.
The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is indicated for the treatment of vascular lesions, including angiomas, telangiectasia and other benign vascular lesions, the treatment of Pseudofolliculitis Barbae (PFB). The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is also indicated for hair removal, permanent hair reduction* and the treatment of benign pigmented lesions and leg veins.
- Note: 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.
Modified Device Description:
The modified LightSheer Desire Light Laser System is a non-invasive aesthetic laser system that delivers pulsed infrared laser light with a wavelength ranging from 790-830 nm (805 nm nominal). The system consists of a laser console and two optional handpieces, ET or XC, which can be connected to the console, one at a time, via a universal plug-in connector and an umbilical cable.
The ET handpiece; delivers laser energy through a 9mm tip up to 81 J maximum. The settings for this handpiece are selectable pulse duration from 5-400 ms, selectable fluency from 10-100 J/cm² and a pulse repetition rate up to 3 Hz maximum. The XC handpiece; delivers laser energy through a 12mm x 12mm tip up to 58 J maximum. The settings for this handpiece are selectable pulse duration from 5-400 ms, selectable fluency from 10-40 J/cm² and a pulse repetition rate up to 3 Hz maximum
The laser system delivers pulsed infrared laser light from the diode array in the ET or XC handpiece to the treatment area. In standard use, the handpiece is pressed against the patient's skin and a pulse of light is delivered. To initiate energy output, the system requires redundant activation of the handpiece enable button and the handpiece trigger button while the system is in the Ready mode.
The ET and XC handpieces include a chilled sapphire tip that is water-cooled to provide active skin cooling. The physician is able to control the settings of laser energy from the LCD display on the main console.
Special 510(k) LightSheer Desire Light Laser System
5
Substantial Equivalence
The intended use and indications for use of the LightSheer Desire Light Laser System are identical to the intended use and indications for use of its predicate device. In addition, the same technological characteristics and principles of operation apply for both systems. The modifications introduced to the subject LightSheer Desire Light Laser System as compared to the predicate system are designed and intended mainly for updating the system industrial design to form a table top console and increased user convenience.
Performance testing was conducted in order to demonstrate the performance of the LightSheer Desire Light Laser System and its substantial equivalence, with respect to the safety and effectiveness, to the cleared predicate system. The following activities were performed:
- Risk analysis activities in compliance with the requirements of ISO 14971.
- . Electrical and laser safety and electromagnetic compatibility testing as required to conform to with the following performance standards:
- । EN 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- requirements and tests.
- EN 60601-1: Medical electrical equipment Part 1: General requirements for । basic safety and essential performance.
- EN 60601-2-22: Medical electrical equipment- part 2: particular requirements for । the safety of diagnostic and therapeutic laser equipment.
- । EN 60825-1: Safety of laser products-Part 1: Equipment classification and requirements.
- Software verification and validation testing.
- . Environmental testing demonstrating the ability of the subject system to withstand variant operation, storage and transportation conditions.
- . System testing (e.g. handpieces use and authorization, treatment parameters, energy measurements, handpiece replacement, handpiece cooling, safety controls).
Test results indicated that the subject LightSheer Desire Light Laser System performs in accordance with its requirements and specifications, in similarity to its predicate device. Consequently, the LightSheer Desire Light Laser System was found to perform as well as its predicate, to be as safe and effective for its intended use as its predicate, and is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issues.