LightSheer Desire Light Laser System

Lumenis, Inc.

Country / region:Israel (IL)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

Israel (IL)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

4

Device details

FDA 510(k) registration fields

K number
K151947
Device name
LightSheer Desire Light Laser System
Country / region
Israel(IL)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2015-07-15
Decision date
2015-08-12
Submission type
Special
Technology type
Diode(AI inferred)
Clinical applications
Hair removalVascular treatment
Primary application
Hair removal
Classification source
AI classified

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.

Intended 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.

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 x 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.

Summary parsed at:2026-06-01 06:11:26 UTC

Predicate devices

1

K151947 references 1 predicate/reference device

Cited as predicate

4

4 submissions cite K151947 as a predicate