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Fat Reducing Low Level Laser

Page Type
Product Code
Definition
Non-invasive reduction in fat layer for body contouring
Physical State
laser system that emits laser energy in the red spectrum
Technical Method
use of low level laser energy to create pores in adipocyte cells to release lipoproteins
Target Area
adipocyte cells within the fat layer of the body, this could include wasit, thighs, abdomin, hips, etc...
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?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
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]

Fat Reducing Low Level Laser

Page Type
Product Code
Definition
Non-invasive reduction in fat layer for body contouring
Physical State
laser system that emits laser energy in the red spectrum
Technical Method
use of low level laser energy to create pores in adipocyte cells to release lipoproteins
Target Area
adipocyte cells within the fat layer of the body, this could include wasit, thighs, abdomin, hips, etc...
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?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
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]