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Lipoaspirate Washing System For Aesthetic Body Contouring

AuraGen Aesthetics LLC

The following data is part of a premarket notification filed by Auragen Aesthetics Llc with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

• Device ID: BK190433
• 510k Number: BK190433
• Device Name: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
• Classification: Lipoaspirate Washing System For Aesthetic Body Contouring
• Applicant: AuraGen Aesthetics LLC 11 Dellbrook Rd Weston, MA 02493 US
• Product Code: QKL
• CFR Regulation Number: 878.5040 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Traditio
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-16
• Decision Date: 2020-03-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860003492703	BK190433	0
00810076894621	BK190433	0