(99 days)
Not Found
Not Found
No
The description focuses on the laser technology, handpieces, and physical parameters, with no mention of AI or ML.
Yes
The device is indicated for the treatment of various medical conditions such as vascular lesions, pseudofolliculitis barbae, and benign pigmented lesions, which falls under the definition of a therapeutic device.
No
The document describes the device as a laser system intended for surgical, aesthetic, and cosmetic applications such, as hair removal, vascular lesion treatment, and benign pigmented lesion treatment. These are all therapeutic or aesthetic procedures, not diagnostic ones. There is no mention of the device being used to identify or analyze medical conditions.
No
The device description clearly details a physical laser system with a console, handpieces, and umbilical cables, indicating it is a hardware-based medical device.
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 treating various skin conditions and hair removal. These are all procedures performed directly on the patient's body.
- Device Description: The description details a laser system that delivers light energy to the patient's skin. This is an external application of energy, not a test performed on a sample taken from the body.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing tests in a laboratory setting, or providing diagnostic information based on the analysis of such samples.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
LightSheer® Duet™ Laser Systems with LightSheer® ET™ Laser Handpiece is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The LightSheer® Duet™ Laser System with LightSheer® ET™ Laser Handpiece is also intended for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins.
LightSheer® Duet™ Laser Systems with LightSheer® HS™ Laser Handpiece is intended for the treatment of benign vascular and pigmented lesions, hair removal, and permanent hair reduction.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The LightSheer Duet Laser System is a non-invasive aesthetic laser. The system delivers pulsed infrared laser light with a wavelength ranging from 790 - 950 nm (800 nm nominal) and has two unique treatment handpieces. One handpiece is the LightSheer® ET™ 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 LightSheer® HS™ handpiece, which delivers laser energy from a 22 x 35 mm diode array up to 45 J maximum. The settings for this handpiece are pulse duration from 10 - 30 ms, selectable fluence from 3 - 5.2 J/cm2 and multiple pulsing up to 3 pulses.
The complete system consists of a console and two handpieces connected to the system by umbilical cables. 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 LightSheer ET handpiece tip is watercooled to provide active skin cooling. The LightSheer HS handpiece tip uses vacuum and lower laser energy densities which reduces skin heating. The physician is able to control the settings of laser energy from the LCD display on the main console.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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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): 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.
Not Found
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/0 description: The image shows the logo for Lumenis. The logo consists of a stylized letter "L" inside of a circle, followed by the word "LUMENIS" in all capital letters. Below the company name is the tagline "Enhancing life. Advancing technology."
APR
K053628
510(k) Summary
| Applicant: | Lumenis, Inc |
|---|---|
| Address: | 2400 Condensa Street |
| Santa Clara, California 95051 | |
| USA | |
| Contact Person: | Connie Hoy |
| Global Director of Regulatory Affairs | |
| and Quality Assurance | |
| Contact Numbers: | (408) 764-3303 Phone |
| (408) 764-3500 Fax | |
| Preparation Date: | December 28, 2005 |
| Device Trade Name: | LightSheer® Duet™ Laser System |
| Common Name: | Pulsed Diode Array Laser |
| Classification Name: | Laser surgical instrument for use in General and |
| Plastic Surgery and in Dermatology (see 21 CFR | |
| 878.4810). | |
| Product Code: GEX | |
| Panel: 79 | |
| Legally-Marketed Predicate Device: | Lumenis, Inc. LightSheer® Pulsed Diode Array |
| Laser System and AesThera Corporation AIP™ |
Intense Pulsed Light System.
Lomenis Inc. 2400 Condensa Street Santa Clara, CA 95051 USA t 408.764.3000 1 800.635.1313 1 408.764.3999 ww.lumenis.com
1
System Description:
The LightSheer Duet Laser System is a non-invasive aesthetic laser. The system delivers pulsed infrared laser light with a wavelength ranging from 790 - 950 nm (800 nm nominal) and has two unique treatment handpieces. One handpiece is the LightSheer® ET™ 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 LightSheer® HS™ handpiece, which delivers laser energy from a 22 x 35 mm diode array up to 45 J maximum. The settings for this handpiece are pulse duration from 10 - 30 ms, selectable fluence from 3 - 5.2 J/cm2 and multiple pulsing up to 3 pulses.
The complete system consists of a console and two handpieces connected to the system by umbilical cables. 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 LightSheer ET handpiece tip is watercooled to provide active skin cooling. The LightSheer HS handpiece tip uses vacuum and lower laser energy densities which reduces skin heating. The physician is able to control the settings of laser energy from the LCD display on the main console.
Intended Use of the Device:
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.
LightSheer® Duet™ Laser Systems with LightSheer® ET™ Laser Handpiece is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The LightSheer® Duet™ Laser System with LightSheer® ET™ Laser Handpiece is also intended for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins.
LightSheer® Duet™ Laser Systems with LightSheer® HS™ Laser Handpiece is intended for the treatment of benign vascular and pigmented lesions, hair removal, and permanent hair reduction.
2
s 36/i
Image /page/2/Picture/2 description: The image shows the Lumenis logo. The logo consists of a stylized letter "L" inside a circle on the left, followed by the word "LUMENIS" in a sans-serif font. Below the word "LUMENIS" is the tagline "Enhancing Life. Advancing technology."
Substantial Equivalence:
The specifications and indications for use of the LightSheer Duet Laser System are the same or very similar to those of the claimed pr dicate devices. The LightSheer Duet Laser System has the same or very similar indications for use for which the claimed predicates have been cleared. Based on the icregoing, the LightSheer Duet Laser System is substantially equivalent to the legally-1 1arketed claimed predicate devices for the purposes of this 510(k) submission.
Lumenis Inc. 2400 Condensa Street Santa Clara, CA 95051 DSA t 408.764.3000 1 800.635.131 3 1-408.764.3000 www.lumenis.com
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is written around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2006 APR
Lumenis, Inc. c/o Ms. Connie Hoy Global Director of Regulatory Affairs and Quality Assurance 2400 Condensa Street Santa Clara, California 95051
Re: K053628
Trade/Device Name: LightSheer® Duet™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: II Product Code: GEX Dated: March 1. 2006 Received: March 3, 2006
Dear Ms. Hoy:
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 cither 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
4
Page 2 – Ms. Connie Hoy
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
Mark N. Melkerson
Mark N. Melke Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _ İC 5 14 20
Device Name: LightSheer® Duet™ Laser System
Indications for Use:
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.
LightSheer® Duet™ Laser Systems with LightSheer® ET™ Laser Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The LightSheer® Duet™ Laser System with LightSheer® ET™ Laser Handpiece is also indicated for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins.
LightSheer® Duet™ Laser Systems with LightSheer® HS™ Laser Handpiece is indicated for the treatment of benign vascular and pigmented lesions, hair removal, and permanent hair reduction.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use | (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
eamoll
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number_ Kos 3628
Lumenis 510(k) Submission: LightSheer Duet Laser System