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Laser For Disruption Of Adipocyte Cells For Aesthetic Use

Page Type
Product Code
Definition
Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
Physical State
The device may include up to three rectangular applicator heads with sapphire glass and dimensions of 4 cm x 6 cm. The laser may be 1064 nm and range in power density from 0.9-1.4 W/cm2.
Technical Method
Laser energy is delivered to the adipose tissue to elevate temperature to 42-47 C for disruption of adipocyte cells. Subsequently, the adipocyte cells release fat and lipids resulting in reduction of the adipose tissue.
Target Area
Areas of the body for treatment such as the flank, abdomen, thighs, waist, hips
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.5400
GMP Exempt?
Yes
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.5400 Low level laser system for aesthetic use

§ 878.5400 Low level laser system for aesthetic use

(a) Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.

(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.

[76 FR 20842, Apr. 14, 2011]

Laser For Disruption Of Adipocyte Cells For Aesthetic Use

Page Type
Product Code
Definition
Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
Physical State
The device may include up to three rectangular applicator heads with sapphire glass and dimensions of 4 cm x 6 cm. The laser may be 1064 nm and range in power density from 0.9-1.4 W/cm2.
Technical Method
Laser energy is delivered to the adipose tissue to elevate temperature to 42-47 C for disruption of adipocyte cells. Subsequently, the adipocyte cells release fat and lipids resulting in reduction of the adipose tissue.
Target Area
Areas of the body for treatment such as the flank, abdomen, thighs, waist, hips
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.5400
GMP Exempt?
Yes
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.5400 Low level laser system for aesthetic use

§ 878.5400 Low level laser system for aesthetic use

(a) Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.

(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.

[76 FR 20842, Apr. 14, 2011]