Home / 510(k) Clearances / K023050

510(k) K023050

RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI by Reliant Technologies, Inc. — Product Code IMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2003
Date Received
September 13, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5860
Review Panel
PM
Submission Type

Other clearances by Reliant Technologies, Inc.

  • K080915 — FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES (July 1, 2008)
  • K071051 — FRAXEL III SR LASER SYSTEM AND ACCESSORIES (November 2, 2007)
  • K071621 — RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES (October 9, 2007)
  • K070284 — FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM) (May 17, 2007)
  • K063808 — FRAXEL IV SR LASER SYSTEM (April 27, 2007)
  • K063038 — FRAXEL III SR LASER SYSTEM AND ACCESSORIES (April 27, 2007)
  • K062303 — FRAXEL II SR LASER SYSTEM (January 31, 2007)
  • K060310 — FRAXEL II SR LASER SYSTEM AND ACCESSORIES (March 29, 2006)
  • K053047 — FRAXEL SR LASER SYSTEM (March 20, 2006)
  • K050841 — FRAXEL SR LASER SYSTEM (July 5, 2005)

Other clearances for product code IMG

  • K244041 — Ultrasound Therapy Workstation (XMS-UET2) (October 7, 2025)
  • K153559 — OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy Sy (August 26, 2016)
  • K150436 — ComboRehab (November 13, 2015)
  • K150353 — BTL-4000 (November 13, 2015)
  • K120217 — SONICSTIMU COMBO THERAPEUTIC DEVICE (November 21, 2012)
  • K121059 — SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM (August 7, 2012)
  • K102524 — FUTURA (November 3, 2011)
  • K111482 — SONICATOR PLUS 920 (August 25, 2011)
  • K102190 — WINSTIM (March 17, 2011)
  • K092627 — CT2011 SONICSTIMU PAIN RELIEF DEVICE (January 14, 2010)