Product areas
FDA product code distribution
Lutronic Corporation
Country / region:Korea, Republic of (KR)
510(k) submissions
6
Filtered: GEX
Latest clearance
2022-02-04
Product codes
1
GEX
510(k) submissions
6 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K213569 | HOLLYWOOD SPECTRA Laser System | GEX | Class 2 | 2022-02-04 |
| K203788 | DermaV Laser System | GEX | Class 2 | 2021-03-26 |
| K183566 | CLARITY II Laser System | GEX | Class 2 | 2019-06-14 |
| K173700 | PICOPLUS Laser System | GEX | Class 2 | 2018-06-19 |
| K171009 | LASEMD Laser System | GEX | Class 2 | 2017-06-23 |
| K163196 | ACTION II Laser System | GEX | Class 2 | 2017-05-24 |
Company profile
- Canonical name
- Lutronic Corporation
- Country
- Korea, Republic of(KR)
Cited predicates
13- K083889
—
—
Not ingested - K113588
—
—
Not ingested - K202503
Chrome
- K153671
Family of CoolGlide Aesthetic Lasers
- K183566
CLARITY II Laser System
- K080735
—
—
Not ingested - K130199
—
—
Not ingested - K141425
—
—
Not ingested - K163222
Discovery Pico Family
- K172077
Cutera enlighten III Laser System
- K130193
—
—
Not ingested - K150140
MCL 31 Dermablate
- K153229
Superbium
Lutronic Corporation references 13 predicate/reference devices
Cited as predicate
11- K253765
VANISH PRO
- K251981
Boston PICO (Boston PICO)
- K251699
The Botticelli (Model: Athena)
- K250165
Pastelle
- K241527
Pastelle Pro
- K240752
DEKA TORO
- K223727
Lavieen
- K203788
DermaV Laser System
- K200116
PicoSecond Nd: YAG Laser System
- K192331
LaseMD LEO Laser System
- K182173
Joule System
11 submissions cite Lutronic Corporation as a predicate