Labtician Ophthalmics, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Labtician Ophthalmics, Inc.” (first 1999, latest 2000), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 77 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 |
|---|---|---|---|
| MML | Weights, Eyelid, External | 2 | 2 |
| HJX | Reader, Prism, Ophthalmic | 1 | 1 |
| LOG | Catheter, Balloon For Retinal Reattachment | 1 | 0 |
Review panels
- Ophthalmic (4)
Most recent Labtician Ophthalmics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000544 | BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 | HJX | 2000-03-09 | 20 |
| K990224 | LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET | MML | 1999-04-12 | 77 |
| K983607 | LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS | MML | 1999-01-08 | 86 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P930024 | PMA | GRIESHABER SCLERAL BUCKLING BALLOON CATHETER | 1994-06-02 |
Recalls
openFDA lists no recalls under a recalling firm named Labtician Ophthalmics, 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.
- Labtician Products, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Labtician Ophthalmics, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Labtician Ophthalmics, Inc.” (first 1999, latest 2000), plus 1 PMA decision, across 3 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 Labtician Ophthalmics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Labtician Ophthalmics, Inc. is 77 days.
Which FDA product codes appear under Labtician Ophthalmics, Inc.?
The most frequent FDA product codes under this applicant name are MML (Weights, Eyelid, External, 2); HJX (Reader, Prism, Ophthalmic, 1); LOG (Catheter, Balloon For Retinal Reattachment, 1).
Next steps
- See all 3 Labtician Ophthalmics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MML, Labtician Ophthalmics, 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.