510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K172111Substantially Equivalent

Vevazz LED

Vevazz, LLC, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172111 is the FDA 510(k) clearance record for Vevazz LED, a class II device, cleared for Vevazz, LLC on under FDA product code OLI (Fat Reducing Low Level Laser). FDA's definition for product code OLI reads: "Non-invasive reduction in fat layer for body contouring". FDA records list 2 510(k) clearances for Vevazz, LLC, from to . As of , FDA records show no recalls naming K172111.

Clearance record

Decision date
Received
(132 days to decision)
Product code
OLI Fat Reducing Low Level Laser
Regulation
21 CFR 878.5400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Vevazz, LLC 3839 Mckinney Ave. #251, Dallas TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLI

Trailing 12 months
5 clearances under product code OLI in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OLI, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260