510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K852405Substantially Equivalent

Lasersafe Personnel and Patient Shields

Lasersafe, Inc., Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852405 is the FDA 510(k) clearance record for LASERSAFE PERSONNEL AND PATIENT SHIELDS, a class I device, cleared for Lasersafe, Inc. on under FDA product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)). FDA records list 3 510(k) clearances for Lasersafe, Inc., from to . As of , FDA records show no recalls naming K852405.

Clearance record

Decision date
Received
(117 days to decision)
Product code
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Regulation
21 CFR 868.5240
Device class
Class I
Review panel
Anesthesiology
Applicant
Lasersafe, Inc. 641 Ridgefield Ave., Pittsburgh PA
Third party review
No

Clearances, product code CAI

Trailing 12 months

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

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