Biolitec Medical Devices, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Biolitec Medical Devices, Inc.” (first 2011, latest 2012), across 1 product code in 1 review panel. Median 510(k) review time under this name: 37 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 | 5 | 32 |
| 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 | 9 | 9 |
Review panels
Most recent Biolitec Medical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120231 | EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL) | GEX | 2012-04-24 | 90 |
| K113688 | MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM | GEX | 2012-03-13 | 89 |
| K113858 | MEGABEAM ENDO-ENT PROBE | GEX | 2012-01-24 | 25 |
| K113709 | MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE | GEX | 2012-01-20 | 32 |
| K113792 | MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE | GEX | 2012-01-19 | 27 |
| K112987 | TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM | GEX | 2011-12-16 | 71 |
| K112299 | ENDOVASCULAR LASER VEIN SYSTEM KIT | GEX | 2011-11-03 | 85 |
| K112442 | RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM | GEX | 2011-09-30 | 37 |
| K112324 | CERALAS 980NM DIODE LASER FAMILY | GEX | 2011-09-06 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named Biolitec Medical Devices, 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.
- Biolitec, Inc. (28 510(k)s)
- Biolitec Sia (1 510(k)s)
- Biolitec Sia (Latvia) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biolitec Medical Devices, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Biolitec Medical Devices, Inc.” (first 2011, latest 2012), across 1 product code 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 Biolitec Medical Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biolitec Medical Devices, Inc. is 37 days.
Which FDA product codes appear under Biolitec Medical Devices, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 9).
Next steps
- See all 9 Biolitec Medical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Biolitec Medical Devices, 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.