Home / 510(k) Clearances / K043586

510(k) K043586

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

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

Other clearances by Mettler Electronics Corp.

  • K113017 — SYS*STIM 240 (June 26, 2012)
  • K111482 — SONICATOR PLUS 920 (August 25, 2011)
  • K091540 — MTD 4000 (October 8, 2009)
  • K071137 — SONICATOR PLUS 940, MODEL ME940 (August 1, 2007)
  • K053546 — SONICATOR 740, MODEL ME 740 (May 4, 2006)
  • K042554 — AUTO THERM 390, MODEL ME 390 (October 8, 2004)
  • K031017 — SYS*STIM 208 AND 208A (May 30, 2003)
  • K023083 — SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800 (February 28, 2003)
  • K022458 — AUTO*THERM 395, MODEL ME 395 (September 26, 2002)
  • K013192 — SONICATOR PLUS 930, MODEL ME 930 (October 17, 2001)

Other clearances for product code ILY

  • K242755 — Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CH (May 19, 2025)
  • K231997 — SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) (October 15, 2024)
  • K223642 — LED Lip Perfector, model: ZC-05 (March 9, 2023)
  • K221189 — OLIZ LTB-1000A (August 29, 2022)
  • K213524 — CytonPro-5000 (August 10, 2022)
  • K202028 — dermalux Flex MD (December 16, 2020)
  • K171087 — AXON IR Heat Lamp (July 7, 2017)
  • K163079 — HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM ( (June 13, 2017)
  • K170068 — Softcure 96 (May 5, 2017)
  • K162590 — Bashan TDP Heat Lamp (February 14, 2017)