Soliton, Inc.

Country / region:United States (US)

510(k) submissions

5

Latest clearance

2021-11-05

Product codes

1

GEX

Cited as predicate

7

Product areas

FDA product code distribution

510(k) submissions

5 total

K number	Device name	Product code	Class	Decision date
K212502	Resonic Rapid Acoustic Pulse Device	GEX	Class 2	2021-11-05
K210964	Resonic Rapid Acoustic Pulse Device	GEX	Class 2	2021-04-27
K201801	Rapid Acoustic Pulse Device	GEX	Class 2	2021-01-29
K200331	Rapid Acoustic Pulse Device	GEX	Class 2	2020-03-10
K190542	Soliton Acoustic Wave Device	GEX	Class 2	2019-05-24

Company profile

Canonical name: Soliton, Inc.
Country: United States(US)

Cited predicates

7

K201801
Rapid Acoustic Pulse Device
Soliton, Inc.
K210964
Resonic Rapid Acoustic Pulse Device
Soliton, Inc.
K201801
Rapid Acoustic Pulse Device
Soliton, Inc.
K102541
—
—
Not ingested
K200331
Rapid Acoustic Pulse Device
Soliton, Inc.
K190542
Soliton Acoustic Wave Device
Soliton, Inc.
K150212
—
—
Not ingested

Soliton, Inc. references 7 predicate/reference devices

Cited as predicate

7

K222629
Resonic Rapid Acoustic Pulse Device
Zeltiq Aesthetics, Inc.
K222629
Resonic Rapid Acoustic Pulse Device
Zeltiq Aesthetics, Inc.
K212502
Resonic Rapid Acoustic Pulse Device
Soliton, Inc.
K212502
Resonic Rapid Acoustic Pulse Device
Soliton, Inc.
K210964
Resonic Rapid Acoustic Pulse Device
Soliton, Inc.
K201801
Rapid Acoustic Pulse Device
Soliton, Inc.
K200331
Rapid Acoustic Pulse Device
Soliton, Inc.

7 submissions cite Soliton, Inc. as a predicate