510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K001263Substantially Equivalent

Sharplan Lasers, Inc. Pulsed Cth:yag Holmium Surgical Laser, Model 2040

E S C Sharplan, Norwood MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K001263 is the FDA 510(k) clearance record for SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040, a class II device, cleared for E S C Sharplan 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 E S C Sharplan. As of , FDA records show no recalls naming K001263.

Clearance record

Decision date
Received
(16 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
E S C Sharplan 100 Morse St., Norwood MA
510(k) summary
Summary
Third party review
No

Clearances, product code GEX

Trailing 12 months
68 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 20260