Cell Robotics, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Cell Robotics, Inc.” (first 1997, latest 2003), across 1 product code 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 | 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 | 9 | 9 |
Review panels
Most recent Cell Robotics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033799 | CLINICAL LASETTE P-200 | GEX | 2003-12-22 | 17 |
| K021946 | CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM | GEX | 2002-09-11 | 90 |
| K983673 | LASETTE | GEX | 1999-01-15 | 87 |
| K981746 | CELL ROBOTICS' LASETTE | GEX | 1998-12-07 | 203 |
| K982230 | LASETTE LASER SKIN PERFORATOR | GEX | 1998-09-24 | 177 |
| K981149 | LASETTE LASER SKIN PERFORATOR | GEX | 1998-06-29 | 90 |
| K973431 | LASETTE | GEX | 1997-10-28 | 48 |
| K965124 | LASETTE | GEX | 1997-08-14 | 234 |
| K970461 | CELL ROBOTICS ER: YAG SURGICAL LASER | GEX | 1997-07-11 | 155 |
Recalls
openFDA lists no recalls under a recalling firm named Cell Robotics, 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.
- Cell Analysis, Inc. (1 510(k)s)
- Cell Bio-Systems, Inc. (1 510(k)s)
- Cell Constructs I, LLC (1 510(k)s)
- Cell Culture Laboratories (1 510(k)s)
- Cell Ent., Inc. (1 510(k)s)
- Cell Gen Therapeutics, LLC (1 510(k)s)
- CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cell Robotics, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Cell Robotics, Inc.” (first 1997, latest 2003), 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 Cell Robotics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cell Robotics, Inc. is 90 days.
Which FDA product codes appear under Cell Robotics, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 9).
Next steps
- See all 9 Cell Robotics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Cell Robotics, 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.