Energy Life Systems Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Energy Life Systems Corp.” (first 1994, latest 1995), across 1 product code in 1 review panel. Median 510(k) review time under this name: 40 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 | 5 | 5 |
Review panels
Most recent Energy Life Systems Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951933 | UROTEK RE-USABLE FIBEROPTIC CABLE | GEX | 1995-05-26 | 31 |
| K945560 | UROTEK LASER CATHETER | GEX | 1995-01-18 | 79 |
| K945563 | CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM)) | GEX | 1994-12-15 | 38 |
| K943409 | SIDE-FIRING UROLOGIC REFRACTIVE FIBER | GEX | 1994-08-23 | 40 |
| K934389 | UROTEK LASER CATHETER | GEX | 1994-02-03 | 147 |
Recalls
openFDA lists no recalls under a recalling firm named Energy Life Systems Corp..
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.
- Energy Concepts, Inc. (1 510(k)s)
- Energy Delivery Solutions (1 510(k)s)
- Energy Resources International Co., Ltd. (1 510(k)s)
- Energy Resources International Co., Ltd. Hsinchu Branch (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Energy Life Systems Corp.?
FDA lists 5 510(k) clearances under the applicant name “Energy Life Systems Corp.” (first 1994, latest 1995), 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 Energy Life Systems Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Energy Life Systems Corp. is 40 days.
Which FDA product codes appear under Energy Life Systems Corp.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 5).
Next steps
- See all 5 Energy Life Systems Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Energy Life Systems Corp.'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.