510(k) K024307
K024307 is an FDA 510(k) premarket notification submitted by Sybaritic, Inc. for the device "DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on Jul 2, 2003. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 2, 2003
- Date Received
- Dec 24, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5300
- Review Panel
- PM
- Submission Type
- 510(k)