510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251298Substantially Equivalent

Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)

Clinical Laserthermia Systems AB, Lund, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251298 is the FDA 510(k) clearance record for Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6), a class II device, cleared for Clinical Laserthermia Systems, AB on under FDA product code ONO (Neurosurgical Laser With Mr Thermography). FDA's definition for product code ONO reads: "Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery". FDA records list 6 510(k) clearances for Clinical Laserthermia Systems, AB, from to . As of , FDA records show no recalls naming K251298.

Clearance record

Decision date
Received
(129 days to decision)
Product code
ONO Neurosurgical Laser With Mr Thermography
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Clinical Laserthermia Systems, AB Scheelevägen 2, Lund, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONO

Trailing 12 months
3 clearances under product code ONO in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ONO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260