510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K862521Substantially Equivalent

Bausch & Lomb Gr-3 Refractor

Bausch & Lomb Incorporated, Rochester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862521 is the FDA 510(k) clearance record for BAUSCH & LOMB GR-3 REFRACTOR, a class I device, cleared for Bausch & Lomb, Inc. on under FDA product code HKO (Refractometer, Ophthalmic). FDA records list 131 510(k) clearances for Bausch & Lomb Incorporated, from to . As of , FDA records show no recalls naming K862521.

Clearance record

Decision date
Received
(10 days to decision)
Product code
HKO Refractometer, Ophthalmic
Regulation
21 CFR 886.1760
Device class
Class I
Review panel
Ophthalmic
Applicant
Bausch & Lomb, Inc. 1400 N. Goodman St., Rochester NY
Third party review
No

Clearances, product code HKO

Trailing 12 months

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

FDA records show no clearances under product code HKO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HKO, 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