Asclepion Laser Technologies GmbH: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Asclepion Laser Technologies GmbH” (first 2004, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 134 days. Since 2017 the median was 185 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 244 |
| 2013 | 0 | — |
| 2014 | 3 | 395 |
| 2015 | 4 | 132 |
| 2016 | 0 | — |
| 2017 | 1 | 331 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 185 |
| 2021 | 0 | — |
| 2022 | 2 | 268 |
| 2023 | 1 | 432 |
| 2024 | 4 | 127 |
| 2025 | 1 | 29 |
| 2026 | 1 | 27 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Asclepion Laser Technologies GmbH took a median 185 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 27 | 27 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
Review panels
Most recent Asclepion Laser Technologies GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261094 | YellowStar | GEX | 2026-04-29 | 27 |
| K253100 | MultiPulse TFL | GEX | 2025-10-23 | 29 |
| K240831 | MultiCut Solo | GCJ | 2024-11-06 | 225 |
| K241600 | Dermablate | GEX | 2024-07-03 | 29 |
| K240816 | MeDioStar | GEX | 2024-04-23 | 29 |
| K231876 | MultiPulse HoPLUS | GEX | 2024-02-22 | 241 |
| K213597 | MultiCut Solo | GCJ | 2023-01-18 | 432 |
| K213889 | PicoStar | GEX | 2022-04-22 | 130 |
| K210634 | MCL 31 Dermablate System | GEX | 2022-04-13 | 406 |
| K192483 | MeDioStar | GEX | 2020-03-13 | 185 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Asclepion Laser Technologies GmbH.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Asclepion Laser Technologies GmbH?
FDA lists 29 510(k) clearances under the applicant name “Asclepion Laser Technologies GmbH” (first 2004, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Asclepion Laser Technologies GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Asclepion Laser Technologies GmbH is 134 days. Since 2017: 185 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Asclepion Laser Technologies GmbH?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 27); GCJ (Laparoscope, General & Plastic Surgery, 2).
Next steps
- See all 29 Asclepion Laser Technologies GmbH clearances with predicates and recalls
- Run predicate analysis for product code GEX, Asclepion Laser Technologies GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.