510(k) K043586

LASER SYS*STIM 540, MODEL ME 540 by Mettler Electronics Corp. — Product Code ILY

K043586 is an FDA 510(k) premarket notification submitted by Mettler Electronics Corp. for the device "LASER SYS*STIM 540, MODEL ME 540". The FDA issued a decision of Substantially Equivalent on May 6, 2005. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Mettler Electronics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2005
Date Received
December 28, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type