510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K131080Substantially Equivalent

Physiolaser Olympic, Single Probes Cw, Cluster Probes Cw, Light Needle, Photonic Satellite

Reimers and Janssen GmbH, Waldkirch, Baden Wurthemberg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K131080 is the FDA 510(k) clearance record for PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE, a class II device, cleared for Reimers and Janssen GmbH on under FDA product code ILY (Lamp, Infrared, Therapeutic Heating). FDA records list 2 510(k) clearances for Reimers and Janssen GmbH, from to . As of , FDA records show no recalls naming K131080.

Clearance record

Decision date
Received
(445 days to decision)
Product code
ILY Lamp, Infrared, Therapeutic Heating
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Reimers and Janssen GmbH Fabrikstr. 22, Waldkirch, Baden Wurthemberg, DE
510(k) summary
Statement
Third party review
No

Clearances, product code ILY

Trailing 12 months
1 clearance under product code ILY 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 ILY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260