Biolitec, Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Biolitec, Inc.” (first 2001, latest 2012), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 | 1 | 183 |
| 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 | 28 | 28 |
| MVF | System, Laser, Photodynamic Therapy | 1 | 0 |
Review panels
Most recent Biolitec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112013 | EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER | GEX | 2012-01-13 | 183 |
| K112253 | CERALAS 147NM DIODE LASER SYSTEM | GEX | 2011-09-20 | 46 |
| K110080 | RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM | GEX | 2011-02-24 | 44 |
| K102755 | CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER | GEX | 2010-12-16 | 84 |
| K101712 | ENDOVASCULAR LAER VEIN SYSTEM KIT | GEX | 2010-10-27 | 131 |
| K100726 | CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM | GEX | 2010-09-15 | 184 |
| K090164 | CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER | GEX | 2009-06-26 | 155 |
| K083682 | 180W CERELAS D 980NM DIODE LASER, MODEL D180 | GEX | 2009-01-09 | 29 |
| K082225 | 15W CERALAS D 1470NM DIODE LASER, MODEL D1470 | GEX | 2008-12-03 | 119 |
| K082263 | CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 | GEX | 2008-10-24 | 77 |
18 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P050021 | PMA | CERALAS I LASER | 2005-12-20 |
Recalls
openFDA lists no recalls under a recalling firm named Biolitec, 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 Medical Devices, Inc. (9 510(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, Inc.?
FDA lists 28 510(k) clearances under the applicant name “Biolitec, Inc.” (first 2001, latest 2012), plus 1 PMA decision, 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 Biolitec, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biolitec, Inc. is 90 days.
Which FDA product codes appear under Biolitec, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 28); MVF (System, Laser, Photodynamic Therapy, 1).
Next steps
- See all 28 Biolitec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Biolitec, 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.