sciton.comJOULE SYSTEM
Sciton, Inc.
SCITON, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2953696 | 3001415984 | SCITON, INC. | 1 | N | 2026-01-01 | 925 COMMERCIAL STREET Palo Alto CA US 94303 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00863249000305 | JOULE - Multi-platform laser/light device for medical use. | 650-493-9155 | service@sciton.com |
| 00863249000312 | BBLs - Intense pulsed light medical device | 650-493-9155 | service@sciton.com |
| 00863249000329 | mJoule - Multi-platform laser/light device for medical use. | 650-493-9155 | service@sciton.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 54632 | 1640688025 | K213761 | Joule diVa System | GEX | 2022-07-19 |
| 54632 | 1009093434 | K182173 | Joule System | GEX | 2019-03-06 |
| 54632 | 1453693871 | K101916 | JOULE MULTI-PLATFORM SYSTEM | GEX | 2011-03-18 |
| 54632 | 1075022167 | K070388 | PROFILE MULTI-PLATFORM SYSTEM | GEX | 2007-05-02 |
| 54632 | 1057763726 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEX | 4 | 2022-07-19 |
PMN#
JOULE 810/940/980 MULTI-PLATFORM SYSTEM
SCITON, INC.
JOULE CLEARSENSE LASER SYSTEM
SCITON, INC.
JOULE MULTI-PLATFORM SYSTEM
SCITON, INC.
PROFILE MULTI-PLATFORM SYSTEM
SCITON, INC.
PROFILE MULTI-PLATFORM SYSTEM
SCITON, INC.
PROFILE 2000/3000 LASER SYSTEM
SCITON, INC.
PROFILE 1320 LASER SYSTEM
SCITON, INC.
PROFILE BBL SYSTEM
SCITON, INC.
CONTOUR PROFILE LASER
SCITON, INC.
SCITON IMAGE HAIR REMOVAL LASER
SCITON, INC.
IMAGE VASCULAR LASER
SCITON, INC.