Precise Optics: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Precise Optics” (first 1979, latest 2003), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 79 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 |
|---|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | 2 |
| EAP | Unit, X-Ray, Intraoral | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
| KPW | Device, Beam Limiting, X-Ray, Diagnostic | 1 | 1 |
| OWB | Interventional Fluoroscopic X-Ray System | 1 | 1 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Precise Optics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030061 | PS 3000 DIGATAL PHOTOSPOT SYSTEM | OWB | 2003-04-07 | 90 |
| K935580 | PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER | OXO | 1994-03-16 | 118 |
| K932878 | PRECISION INTRA-ORAL SCOPES | EIA | 1994-01-06 | 206 |
| K914084 | ENDOSCOPES | GCJ | 1992-01-22 | 140 |
| K914184 | P2020-8-0 BEAM-LIMITING DEVICE | KPW | 1991-11-27 | 70 |
| K911744 | PRECISION OPTICS CORPORATION LAPAROSCOPE | GCJ | 1991-07-26 | 99 |
| K903459 | PRECISION OPTICS ENDOSCOPE ADAPTER | FET | 1990-10-26 | 86 |
| K903458 | PRECISION OPTICS IMAGE COUPLER | FET | 1990-10-19 | 79 |
| K903457 | PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) | FET | 1990-10-19 | 79 |
| K827087 | P1808 MOBILE C-ARM IMAGE INTENSIFIER | — | 1982-03-04 | 41 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Precise Optics.
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.
- Precise Optics Photo Medic Equipment, Inc. (2 510(k)s)
- Precise Light Surgical (1 510(k)s)
- Precise Medical Products (1 510(k)s)
- Precise Medical Products, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Precise Optics?
FDA lists 13 510(k) clearances under the applicant name “Precise Optics” (first 1979, latest 2003), across 9 product codes in 4 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 Precise Optics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Precise Optics is 79 days.
Which FDA product codes appear under Precise Optics?
The most frequent FDA product codes under this applicant name are FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 3); GCJ (Laparoscope, General & Plastic Surgery, 2); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 2).
Next steps
- See all 13 Precise Optics clearances with predicates and recalls
- Run predicate analysis for product code FET, Precise Optics'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.