510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883839Substantially Equivalent

Nd:yag Laser Spectacles, Mst Model #Yls-5

Marlo Surgical Technology, Willoughby OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883839 is the FDA 510(k) clearance record for ND:YAG LASER SPECTACLES, MST MODEL #YLS-5, a class I device, cleared for Marlo Surgical Technology on under FDA product code KYP (Snake Bite Suction Kit). FDA's definition for product code KYP reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list 28 510(k) clearances for Marlo Surgical Technology, from to . As of , FDA records show no recalls naming K883839.

Clearance record

Decision date
Received
(88 days to decision)
Product code
KYP Snake Bite Suction Kit
Regulation
21 CFR 880.5740
Device class
Class I
Review panel
General Hospital
Applicant
Marlo Surgical Technology 1810 Joseph Lloyd Pkwy., Willoughby OH
Third party review
No

Clearances, product code KYP

Trailing 12 months

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

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