510(k) K230100
K230100 is an FDA 510(k) premarket notification submitted by Classys, Inc. for the device "SCIZER (SC1-M410)". The FDA issued a decision of Substantially Equivalent on November 3, 2023. The device falls under product code OHV (Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption), a Class II device regulated under 21 CFR 878.4590. Classys, Inc. has at least 3 other 510(k) clearances on record.
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.