Laser Assisted Lipolysis

Product Code: ORK

General & Plastic Surgery Medical Laser Products

Definition: Intended To Be Used For Laser Assisted 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 ORK

5823Laser Assisted LipolysisLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

Total Product Life Cycle (TPLC) Devices

5823Laser Assisted LipolysisLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

FDA Consensus Standards

Laser Assisted Lipolysis [30278]21 CFR §878.4810 🔎
Laser Assisted Lipolysis [38651]21 CFR §878.4810 🔎
Laser Assisted Lipolysis [38649]21 CFR §878.4810 🔎
Laser Assisted Lipolysis [38650]21 CFR §878.4810 🔎
Laser Assisted Lipolysis [34006]21 CFR §878.4810 🔎

Pre-market Notifications for ORK

K090754LIPOCONTROLOSYRIS MEDICAL

Maude Adverse Events

BROAD BAND LIGHT/ BBLSCITON, INC.2018-05-08
FOTOFACIAL DEVELOPED BY DR. PATRICK BITTER, JR.SCITON INC.2018-03-09
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