Pharos Life Corporation: FDA clearances and approvals
Pharos Life Corporation has 5 FDA 510(k) clearances (first 2007, latest 2011), across 4 product codes in 2 review panels. Median 510(k) review time: 214 days.
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 | 2 | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 1 | 1 |
| ONE | Powered Light Based Non-Laser Surgical Instrument | 1 | 1 |
Review panels
Most recent Pharos Life Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110735 | TANDA MAX OTC SYSTEM | OHS | 2011-08-03 | 140 |
| K103415 | TANDA MAX | ONE | 2011-01-03 | 42 |
| K090008 | TANDA RESTORE, MODEL PTSCS | ILY | 2009-10-15 | 286 |
| K080591 | TANDA SKINCARE SYSTEM, MODEL: PTSCS | GEX | 2008-11-14 | 256 |
| K070185 | TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001 | GEX | 2007-08-21 | 214 |
Recalls
openFDA lists no recalls under a recalling firm named Pharos Life Corporation.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Pharos Life Corporation have?
Pharos Life Corporation has 5 FDA 510(k) clearances (first 2007, latest 2011), across 4 product codes in 2 review panels.
How long does FDA take to clear Pharos Life Corporation's 510(k)s?
The median time from FDA receipt to decision across Pharos Life Corporation's cleared 510(k)s is 214 days.
What devices does Pharos Life Corporation make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 2); ILY (Lamp, Infrared, Therapeutic Heating, 1); OHS (Light Based Over The Counter Wrinkle Reduction, 1).
Has Pharos Life Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Pharos Life Corporation. Related entities may recall under other names.
Next steps
- See all 5 Pharos Life Corporation clearances with predicates and recalls
- Run predicate analysis for product code GEX, Pharos Life Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.