510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K160012Substantially Equivalent

O-pel Laser and families of probe delivery devices

Precise Light Surgical, Campbell CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160012 is the FDA 510(k) clearance record for O-pel Laser and families of probe delivery devices, a class II device, cleared for Precise Light Surgical 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 one 510(k) clearance for Precise Light Surgical. As of , FDA records show no recalls naming K160012.

Clearance record

Decision date
Received
(150 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
Precise Light Surgical 310 W. Hamilton Ave. Suite 210, Campbell CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GEX

Trailing 12 months
70 clearances under product code GEX in the twelve months to October 2026, November 2025 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code GEX, trailing twelve months
MonthClearances
November 202511
December 20255
January 20264
February 20266
March 20267
April 20265
May 20268
June 20263
July 20264
August 20264
September 202611
October 20262