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
K250224Substantially Equivalent

handLITE (TN19S)

iSMART Developments, Ltd., Birmingham, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250224 is the FDA 510(k) clearance record for handLITE (TN19S), a class II device, cleared for iSMART Developments, Ltd. on under FDA product code ONE (Powered Light Based Non-Laser Surgical Instrument). FDA's definition for product code ONE reads: "A light based Non-Laser device typically indicated to be used for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics...". FDA records list 4 510(k) clearances for iSMART Developments, Ltd., from to . As of , FDA records show no recalls naming K250224.

Clearance record

Decision date
Received
(81 days to decision)
Product code
ONE Powered Light Based Non-Laser Surgical Instrument
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
iSMART Developments, Ltd. 129 Green Ln.s, Wylde Green, Birmingham, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONE

Trailing 12 months

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

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