510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912347Substantially Equivalent

Bipure 1000

Laser Engineering, Inc., Milford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912347 is the FDA 510(k) clearance record for BIPURE 1000, a class II device, cleared for Laser Engineering, Inc. on under FDA product code FYD (Apparatus, Exhaust, Surgical). FDA records list 18 510(k) clearances for Laser Engineering, Inc., from to . As of , FDA records show no recalls naming K912347.

Clearance record

Decision date
Received
(118 days to decision)
Product code
FYD Apparatus, Exhaust, Surgical
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Laser Engineering, Inc. 113 Cedar St., Milford MA
510(k) summary
Statement
Third party review
No

Clearances, product code FYD

Trailing 12 months

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

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