510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853556Substantially Equivalent

Laser Iras

Randwal Instrument Co., Inc., Southbridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853556 is the FDA 510(k) clearance record for LASER IRAS, a class II device, cleared for Randwal Instrument Co., Inc. on under FDA product code HPJ (Instrument, Visual Field, Laser). FDA records list 6 510(k) clearances for Randwal Instrument Co., Inc., from to . As of , FDA records show no recalls naming K853556.

Clearance record

Decision date
Received
(67 days to decision)
Product code
HPJ Instrument, Visual Field, Laser
Regulation
21 CFR 886.1360
Device class
Class II
Review panel
Ophthalmic
Applicant
Randwal Instrument Co., Inc. 278 Worcester St., Southbridge MA
Third party review
No

Clearances, product code HPJ

Trailing 12 months

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

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