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
K012873Substantially Equivalent

Documenting Laser Slit Lamp, Dp 2010

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

K012873 is the FDA 510(k) clearance record for DOCUMENTING LASER SLIT LAMP, DP 2010, a class II device, cleared for Bausch & Lomb, Inc. on under FDA product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered). FDA records list 131 510(k) clearances for Bausch & Lomb Incorporated, from to . As of , FDA records show no recalls naming K012873.

Clearance record

Decision date
Received
(84 days to decision)
Product code
HJO Biomicroscope, Slit-Lamp, Ac-Powered
Regulation
21 CFR 886.1850
Device class
Class II
Review panel
Ophthalmic
Applicant
Bausch & Lomb, Inc. 9342 Jeronimo Rd., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code HJO

Trailing 12 months
2 clearances under product code HJO in the twelve months to November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HJO, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260