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510(k) K230100

SCIZER (SC1-M410) by Classys, Inc. — Product Code OHV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2023
Date Received
January 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Device Class
Class II
Regulation Number
878.4590
Review Panel
SU
Submission Type

A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-invasive aesthetic use.

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  • K233104 — SofWave System (December 22, 2023)
  • K232455 — SofWave System (December 14, 2023)
  • K231628 — BeShape One™ Device (September 29, 2023)
  • K231537 — SofWave System (August 28, 2023)
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  • K230019 — SofWave System (March 14, 2023)