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
K982063Substantially Equivalent

Alm Prismalix (Prx) Surgical Light

Alm Surgical Equipment, Inc., Anaheim CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982063 is the FDA 510(k) clearance record for ALM PRISMALIX (PRX) SURGICAL LIGHT, a class II device, cleared for Alm Surgical Equipment, Inc. on under FDA product code FSY (Light, Surgical, Ceiling Mounted). FDA records list 10 510(k) clearances for Alm Surgical Equipment, Inc., from to . As of , FDA records show one recall naming K982063.

Clearance record

Decision date
Received
(102 days to decision)
Product code
FSY Light, Surgical, Ceiling Mounted
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Alm Surgical Equipment, Inc. 1820 N. Lemon St., Anaheim CA
510(k) summary
Summary
Third party review
No

Clearances, product code FSY

Trailing 12 months

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

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