510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K062258Substantially Equivalent

Genesis Diode Laser

Ivoclar Vivadent, Inc., Amherst NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062258 is the FDA 510(k) clearance record for GENESIS DIODE LASER, a class II device, cleared for Ivoclar Vivadent, Inc. on under FDA product code GEX (Powered Laser Surgical Instrument). FDA's definition for product code GEX reads: "A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue...". FDA records list 97 510(k) clearances for Ivoclar Vivadent, Inc., from to . As of , FDA records show no recalls naming K062258.

Clearance record

Decision date
Received
(229 days to decision)
Product code
GEX Powered Laser Surgical Instrument
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Ivoclar Vivadent, Inc. 175 Pineview Dr., Amherst NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GEX

Trailing 12 months
62 clearances under product code GEX in the twelve months to November 2026, September 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code GEX, trailing twelve months
MonthClearances
December 20255
January 20264
February 20266
March 20267
April 20265
May 20268
June 20263
July 20264
August 20264
September 202611
October 20265
November 20260