Product areas
FDA product code distribution
Asclepion Laser Technologies GmbH
Country / region:United States (US)
510(k) submissions
13 total
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K261094 | YellowStar | GEX | Class 2 | 2026-04-29 |
| K253100 | MultiPulse TFL | GEX | Class 2 | 2025-10-23 |
| K241600 | Dermablate | GEX | Class 2 | 2024-07-03 |
| K240816 | MeDioStar | GEX | Class 2 | 2024-04-23 |
| K231876 | MultiPulse HoPLUS | GEX | Class 2 | 2024-02-22 |
| K213889 | PicoStar | GEX | Class 2 | 2022-04-22 |
| K210634 | MCL 31 Dermablate System | GEX | Class 2 | 2022-04-13 |
| K192483 | MeDioStar | GEX | Class 2 | 2020-03-13 |
| K161257 | MultiPulse HoPLUS | GEX | Class 2 | 2017-03-31 |
| K152153 | MicroSpot Handpiece | GEX | Class 2 | 2015-12-11 |
| K150140 | MCL 31 Dermablate | GEX | Class 2 | 2015-06-05 |
| K143519 | The MeDioStar NeXT Family | GEX | Class 2 | 2015-03-10 |
| K133891 | MULTIPULSE TM+1470 | GEX | Class 2 | 2015-01-30 |
Company profile
- Canonical name
- Asclepion Laser Technologies GmbH
- Country
- United States(US)
Cited predicates
27- K230990
Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
- K133297
—
—
Not ingested - K131081
—
—
Not ingested - K133891
—
—
Not ingested - K220426
—
—
Not ingested - K202258
—
—
Not ingested - K210634
—
—
Not ingested - K170179
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
- K192483
MeDioStar
- K172376
—
—
Not ingested - K150140
—
—
Not ingested - K152153
—
—
Not ingested - K170179
—
—
Not ingested - K191321
—
—
Not ingested - K143519
—
—
Not ingested - K131987
—
—
Not ingested - K140388
—
—
Not ingested - K081541
—
—
Not ingested - K101306
—
—
Not ingested - K132806
—
—
Not ingested - K150140
MCL 31 Dermablate
- K081541
—
—
Not ingested - K101306
—
—
Not ingested - K111851
—
—
Not ingested - K140009
—
—
Not ingested - K102749
—
—
Not ingested - K120231
—
—
Not ingested
Asclepion Laser Technologies GmbH references 27 predicate/reference devices
Cited as predicate
25- K253633
Holmium Laser Therapeutic Apparatus (HZ-40)
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Not ingested - K253100
MultiPulse TFL
Asclepion Laser Technologies GmbH
Not ingested - K252771
Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Not ingested - K252561
BTL-754FF
- K252561
BTL-754FF
- K242251
Litho 60; Litho 100; Litho 150
Not ingested - K241600
Dermablate
Asclepion Laser Technologies GmbH
Not ingested - K240816
MeDioStar
- K234057
NIRVANA
Not ingested - K232236
Echo
Not ingested - K213761
Joule diVa System
- K213252
Dornier Thulio
Not ingested - K210634
MCL 31 Dermablate System
Asclepion Laser Technologies GmbH
Not ingested - K210634
MCL 31 Dermablate System
Asclepion Laser Technologies GmbH
Not ingested - K202041
Opera Evo
Not ingested - K201455
Litho 150, Cyber Ho 150
Not ingested - K192483
MeDioStar
Asclepion Laser Technologies GmbH
Not ingested - K192269
TwinScan 808/755 Laser System
Gme German Medical Engineering GmbH
Not ingested - K180719
InMode Diolaze System
Not ingested - K173002
2940 nm Er:Yag Laser Handpiece
Not ingested - K163196
ACTION II Laser System
Not ingested - K153229
Superbium
Not ingested - K152737
Lite Touch
Not ingested - K152714
Quanta Forte
- K152153
MicroSpot Handpiece
25 submissions cite Asclepion Laser Technologies GmbH as a predicate