Manufacturer
Zeltiq Aesthetics, Inc.Resonic Rapid Acoustic Pulse Device
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K233804
- Device name
- Resonic Rapid Acoustic Pulse Device
- Company
- Zeltiq Aesthetics, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-11-29
- Decision date
- 2024-02-01
- Submission type
- Traditional
- Technology type
- Q-Switched(AI inferred)
- Clinical applications
- OtherSkin tighteningOtherOther
- Primary application
- Other
- Classification source
- AI classified
Indications for Use
The Resonic™ Rapid Acoustic Pulse device is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The Resonic device is also indicated for long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to one year of observation. In addition, the Resonic device can improve the appearance of skin laxity in conjunction with improvement in the appearance of cellulite.
Intended Use
The Resonic™ Rapid Acoustic Pulse device is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The Resonic device is also indicated for long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to one year of observation. In addition, the Resonic device can improve the appearance of skin laxity in conjunction with improvement in the appearance of cellulite.
Device Description
The Resonic™ Rapid Acoustic Pulse device is composed of three parts: the Console, the Handpiece and the replaceable Cartridge. The Console supplies saline to the Handpiece to enable formation of the shock wave within the acoustic pulse chamber. The Handpiece generates acoustic waves in the saline. The acoustic waves pass through the acoustically transparent window of the Cartridge and acoustic ultrasound gel or similar hydrogel pad, which is placed against the surface of the skin to be treated. The subject Resonic device is identical to the previously cleared Resonic device. No changes have been made to the technological characteristics of the subject device to accommodate the update of indication for use.
Summary parsed at:2026-06-01 05:27:07 UTC
Predicate devices
1Resonic Rapid Acoustic Pulse Device
K233804 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
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