Product Code: OYW FDA class 2 21 CFR 878.4810

Laser, Cellulite Appearance

General, Plastic Surgery

The Laser, Cellulite Appearance is a surgical laser device used for the removal of fat through laser lipolysis, intended to improve the appearance of cellulite in the treatment of localized fat deposits. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance, and is eligible for third-party review. The product code is OYW, with regulation number 878.4810 under the General, Plastic Surgery medical specialty.

510(k)s
2
FEI Numbers
6
Registration Numbers
6
Unique Applicants
1
Years Active
1

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Basic Information

Product Code
OYW
Device Class
FDA class 2
Regulation Number
878.4810
Medical Specialty
General, Plastic Surgery
Review Panel
SU
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

For the removal of fat through laser lipolysis.

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K123407 CELLULAZE LASER
K102541 CYNOSURE CELLULAZE LASER

FEI Numbers

This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.