Manufacturer
Soliton, Inc.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
Device details
FDA 510(k) registration fields
- K number
- K201801
- Device name
- Rapid Acoustic Pulse Device
- Company
- Soliton, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-06-30
- Decision date
- 2021-01-29
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Pigment treatmentBody contouring
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
The Rapid Acoustic Pulse Device (RAP) 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 RAP device is also indicated for short-term improvement in the appearance of cellulite.
Intended Use
The Rapid Acoustic Pulse Device (RAP) 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 RAP device is also indicated for short-term improvement in the appearance of cellulite.
Device Description
The Rapid Acoustic Pulse Device (RAP) is designed as an accessory to laser treatments to improve laser tattoo fading efficiency, as well as a standalone device to improve the appearance of cellulite. RAP uses repeated, rapidly rising acoustic waves, releasing pigment particles from the pigment laden macrophage (PLM) and dissipating the laser-induced whitening. This allows multiple laser passes in a single session, resulting in accelerated tattoo fading and fewer office visits to achieve sufficient tattoo fading. When used for improving the appearance of cellulite, the acoustic waves induce physical effects in the fibrous structures, such as the fibrous septa in the subcutaneous tissue. RAP is composed of three parts: the Console, the Hand Piece and the connecting Cable. The Console supplies saline to the Hand Piece to enable formation of the shock wave within the acoustic pulse chamber. The Hand Piece generates acoustic waves in the saline. The acoustic waves pass through the acoustically transparent Window and acoustic ultrasound gel or similar hydrogel pad, which when placed against the surface of the skin to be treated.
Summary parsed at:2026-06-01 05:41:23 UTC
Predicate devices
2—
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Not ingested
Rapid Acoustic Pulse Device
K201801 references 2 predicate/reference devices
Cited as predicate
3Resonic Rapid Acoustic Pulse Device
Resonic Rapid Acoustic Pulse Device
Resonic Rapid Acoustic Pulse Device
3 submissions cite K201801 as a predicate
