510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120257Substantially Equivalent

Mls, Zerona-Ad

Erchonia Medical, Inc., Greenwood Village CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K120257 is the FDA 510(k) clearance record for MLS, ZERONA-AD, a class II device, cleared for Erchonia Medical, Inc. 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 11 510(k) clearances for Erchonia Medical, Inc., from to . As of , FDA records show no recalls naming K120257.

Clearance record

Decision date
Received
(108 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
Erchonia Medical, Inc. 5401 S. Cottonwood Ct., Greenwood Village CO
510(k) summary
Statement
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