Laser, Cellulite Appearance

Product Code: OYW

General & Plastic Surgery Medical Laser Products

Definition: For The Removal Of Fat Through Laser Lipolysis.

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 878.4810


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as OYW

5854Laser, Cellulite AppearanceLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

Total Product Life Cycle (TPLC) Devices

5854Laser, Cellulite AppearanceLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

FDA Consensus Standards

Laser, Cellulite Appearance [30278]21 CFR §878.4810 🔎
Laser, Cellulite Appearance [38651]21 CFR §878.4810 🔎
Laser, Cellulite Appearance [38649]21 CFR §878.4810 🔎
Laser, Cellulite Appearance [38650]21 CFR §878.4810 🔎
Laser, Cellulite Appearance [34006]21 CFR §878.4810 🔎

Pre-market Notifications for OYW

K123407CELLULAZE LASERCYNOSURE, INC.
K102541CYNOSURE CELLULAZE LASERCYNOSURE, INC.

Maude Adverse Events

CYNOSURE CELLULAZE - SLT IIEL.EN. ELECTRONIC ENGINEERING S.P.A.2019-02-08
CYNOSURE CELLULAZE - SLT IIEL. EN. ELECTRONIC ENGINEERING SPA2019-02-06
CYNOSURE CELLULAZE - SLT IIEL.EN. ELECTRONIC ENGINEERING S.P.A.2016-01-25
CYNOSURE CELLULAZE - SLT IIEL.EN. ELECTRONIC ENGINEERING S.P.A.2016-01-20
CYNOSURE CELLULAZE - SLT IIEL.EN. ELECTRONIC ENGINEERING S.P.A.2015-12-18
SLT IICYNOSURE INC2015-08-04
SLT II CELLULAZE2015-04-03
SLT II WITH CELLULAZECYNOSURE, INC.2013-05-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.