Product areas
FDA product code distribution
Laseroptek Co., Ltd.
Country / region:Korea, Republic of (KR)
510(k) submissions
11
Filtered: GEX
Latest clearance
2025-02-07
Product codes
1
GEX
510(k) submissions
11 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K243780 | HELIOS 785 Pico (1754V2) | GEX | Class 2 | 2025-02-07 |
| K230373 | HELIOS 785 Pico | GEX | Class 2 | 2023-05-22 |
| K223588 | PALLAS Premium | GEX | Class 2 | 2023-01-26 |
| K212663 | HELIOS IV 785 | GEX | Class 2 | 2022-06-09 |
| K212573 | PicoLO Premium | GEX | Class 2 | 2021-12-08 |
| K203491 | PicoLO Nd: YAG Picosecond Laser System | GEX | Class 2 | 2021-04-07 |
| K191501 | PALLAS 308/311 Solid-State UV Laser System | GEX | Class 2 | 2020-01-03 |
| K183392 | PicoLO Nd:YAG Picosecond Laser System | GEX | Class 2 | 2019-01-04 |
| K182045 | Lotus III Multi-Pulsed Er: Yag Laser System | GEX | Class 2 | 2018-12-27 |
| K172639 | PALLAS 308/311 Solid-State UV Laser System | GEX | Class 2 | 2017-11-03 |
| K152856 | Helios III | GEX | Class 2 | 2016-06-02 |
Company profile
- Canonical name
- Laseroptek Co., Ltd.
- Country
- Korea, Republic of(KR)
Cited predicates
22- K230373
HELIOS 785 Pico
- K202288
Finebeam
- K191685
PicoWay Laser System
- K212663
HELIOS IV 785
- K191501
PALLAS 308/311 Solid-State UV Laser System
- K193478
XTRAC Momentum Excimer Laser System
- K152856
Helios III
- K170597
PicoWay Laser System
- K203491
PicoLO Nd: YAG Picosecond Laser System
- K170597
PicoWay Laser System
- K172639
PALLAS 308/311 Solid-State UV Laser System
- K170597
PicoWay Laser System
- K083253
—
—
Not ingested - K093162
—
—
Not ingested - K143723
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
- K172639
PALLAS 308/311 Solid-State UV Laser System
- K020847
—
—
Not ingested - K024020
—
—
Not ingested - K062963
—
—
Not ingested - K152856
Helios III
- K083203
—
—
Not ingested - K133254
—
—
Not ingested
Laseroptek Co., Ltd. references 22 predicate/reference devices
Cited as predicate
11- K243780
HELIOS 785 Pico (1754V2)
- K242206
ACTIVO
- K240752
DEKA TORO
- K230373
HELIOS 785 Pico
- K223588
PALLAS Premium
- K212663
HELIOS IV 785
- K212573
PicoLO Premium
- K193266
MIIN
- K191501
PALLAS 308/311 Solid-State UV Laser System
- K182045
Lotus III Multi-Pulsed Er: Yag Laser System
- K172639
PALLAS 308/311 Solid-State UV Laser System
11 submissions cite Laseroptek Co., Ltd. as a predicate