Solos Ophthalmology: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Solos Ophthalmology” (first 1987, latest 1988), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 25 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 2 | 2 |
| HMT | Drape, Patient, Ophthalmic | 1 | 1 |
| HMX | Cannula, Ophthalmic | 1 | 1 |
| HOZ | Sponge, Ophthalmic | 1 | 1 |
Review panels
- Ophthalmic (4)
- General Hospital (1)
Most recent Solos Ophthalmology 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874334 | SOLOS SINGLE USE TITANIUM TIP | HQC | 1988-01-11 | 81 |
| K872611 | SOLOS EYESITE CAP SLEEVE | HQC | 1987-08-10 | 35 |
| K872620 | SOLOS EYESITE DRAPES | HMT | 1987-07-31 | 25 |
| K872612 | SOLOS EYESITE SPONGES | HOZ | 1987-07-31 | 25 |
| K872610 | SOLOS EYESITE CANNULAS | HMX | 1987-07-31 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named Solos Ophthalmology.
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.
- Solos Endoscopy, Inc. (21 510(k)s)
- Solos Mfg. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Solos Ophthalmology?
FDA lists 5 510(k) clearances under the applicant name “Solos Ophthalmology” (first 1987, latest 1988), across 4 product codes in 2 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 Solos Ophthalmology?
The median time from FDA receipt to decision across 510(k)s cleared under the name Solos Ophthalmology is 25 days.
Which FDA product codes appear under Solos Ophthalmology?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 2); HMT (Drape, Patient, Ophthalmic, 1); HMX (Cannula, Ophthalmic, 1).
Next steps
- See all 5 Solos Ophthalmology clearances with predicates and recalls
- Run predicate analysis for product code HQC, Solos Ophthalmology'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.