Heraeus Lasersonics, Inc.: FDA filings under this applicant name
FDA lists 38 510(k) clearances under the applicant name “Heraeus Lasersonics, Inc.” (first 1988, latest 1994), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 76 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 37 | 37 |
| HQF | Laser, Ophthalmic | 1 | 1 |
Review panels
Most recent Heraeus Lasersonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933245 | ULTRALINE II STERILE DISPOSABLE FIBER | GEX | 1994-04-21 | 293 |
| K923896 | HERCULES MODEL 5060 AND 5100 ND:YAG LASER SYSTEMS | GEX | 1992-11-25 | 113 |
| K921807 | ULTRALINE STERILE DISPOSABLE FIBER | GEX | 1992-06-18 | 64 |
| K915578 | ND;YAG SURGICAL LASER SYSTEMS | GEX | 1992-06-15 | 185 |
| K915583 | CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR. | GEX | 1992-03-27 | 105 |
| K912618 | LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY | GEX | 1992-02-27 | 259 |
| K913887 | C02 LASER WAVEGUIDE | GEX | 1991-12-09 | 102 |
| K910530 | CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY | GEX | 1991-10-31 | 265 |
| K913918 | HERAEUS LASERSONICS TACTILASE STERILE DISPOS FIBER | GEX | 1991-09-25 | 22 |
| K913564 | HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE | GEX | 1991-09-16 | 38 |
28 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Heraeus Lasersonics, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Heraeus Kulzer, Inc. (166 510(k)s)
- Heraeus Medical GmbH (13 510(k)s)
- Heraeus Surgical, Inc. (8 510(k)s)
- Heraeus Kulzer GmbH & Co. KG (4 510(k)s)
- Heraeus Medical Components, LLC (4 510(k)s)
- Heraeus Dental Gold Corp. (3 510(k)s)
- Heraeus Med GmbH (3 510(k)s)
- Heraeus, Inc. (1 510(k)s)
- Heraeus Instruments GmbH (1 510(k)s)
- Heraeus Kulzer, Inc., Dental Products Division (1 510(k)s)
- Heraeus Kulzer, LLC (Mitsui Chemicals Group) (1 510(k)s)
- Heraeus Kulzer, LLC, Mitsui Chemicals Group (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Heraeus Lasersonics, Inc.?
FDA lists 38 510(k) clearances under the applicant name “Heraeus Lasersonics, Inc.” (first 1988, latest 1994), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Heraeus Lasersonics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Heraeus Lasersonics, Inc. is 76 days.
Which FDA product codes appear under Heraeus Lasersonics, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 37); HQF (Laser, Ophthalmic, 1).
Next steps
- See all 38 Heraeus Lasersonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Heraeus Lasersonics, Inc.'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.