Product areas
FDA product code distribution
Asclepion Laser Technologies GmbH
Country / region:United States (US)
510(k) submissions
13
Filtered: GEX
Latest clearance
2026-04-29
Product codes
1
GEX
510(k) submissions
13 total · filtered by GEX
| 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
MULTIPULSE TM+1470
- K220426
Fiber Dust PRO
- K202258
ERISE Laser handpiece
- K210634
MCL 31 Dermablate System
- K170179
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
- K192483
MeDioStar
- K172376
Discovery Pico, Discovery Pico Plus
- K150140
MCL 31 Dermablate
- K152153
MicroSpot Handpiece
- K170179
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
- K191321
Primelase Excellence
- K143519
The MeDioStar NeXT Family
- 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)
- K253100
MultiPulse TFL
- 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)
- K252561
BTL-754FF
- K252561
BTL-754FF
- K242251
Litho 60; Litho 100; Litho 150
- K241600
Dermablate
- K240816
MeDioStar
- K234057
NIRVANA
- K232236
Echo
- K213761
Joule diVa System
- K213252
Dornier Thulio
- K210634
MCL 31 Dermablate System
- K210634
MCL 31 Dermablate System
- K202041
Opera Evo
- K201455
Litho 150, Cyber Ho 150
- K192483
MeDioStar
- K192269
TwinScan 808/755 Laser System
- K180719
InMode Diolaze System
- K173002
2940 nm Er:Yag Laser Handpiece
- K163196
ACTION II Laser System
- K153229
Superbium
- K152737
Lite Touch
- K152714
Quanta Forte
- K152153
MicroSpot Handpiece
25 submissions cite Asclepion Laser Technologies GmbH as a predicate