510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K882618Substantially Equivalent

Jedmed/polack Keratoscope Hs/sl

Gamut Ent., Snellville GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882618 is the FDA 510(k) clearance record for JEDMED/POLACK KERATOSCOPE HS/SL, a class I device, cleared for Gamut Ent. on under FDA product code HLR (Keratoscope, Battery-Powered). FDA records list one 510(k) clearance for Gamut Ent. As of , FDA records show no recalls naming K882618.

Clearance record

Decision date
Received
(19 days to decision)
Product code
HLR Keratoscope, Battery-Powered
Regulation
21 CFR 886.1350
Device class
Class I
Review panel
Ophthalmic
Applicant
Gamut Ent. 2121 Fountain Dr. Suite N, Snellville GA
Third party review
No

Clearances, product code HLR

Trailing 12 months

FDA records hold no clearances under product code HLR in the trailing twelve months.

FDA records show no clearances under product code HLR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HLR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260