510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K880503Substantially Equivalent

Mdl-1 Lasertripter

Candela Corporation, Wayland MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880503 is the FDA 510(k) clearance record for MDL-1 LASERTRIPTER, a class II device, cleared for Candela Laser Corp. on under FDA product code FFK (Lithotriptor, Electro-Hydraulic). FDA records list 99 510(k) clearances for Candela Corporation, from to . As of , FDA records show no recalls naming K880503.

Clearance record

Decision date
Received
(130 days to decision)
Product code
FFK Lithotriptor, Electro-Hydraulic
Regulation
21 CFR 876.4480
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Candela Laser Corp. 530 Boston Post Rd., Wayland MA
Third party review
No

Clearances, product code FFK

Trailing 12 months

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

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