Reliant Technologies, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Reliant Technologies, Inc.” (first 1994, latest 2008), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 153 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 | 18 | 18 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 1 | 1 |
Review panels
Most recent Reliant Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080915 | FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES | GEX | 2008-07-01 | 90 |
| K071051 | FRAXEL III SR LASER SYSTEM AND ACCESSORIES | GEX | 2007-11-02 | 203 |
| K071621 | RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES | GEX | 2007-10-09 | 117 |
| K070284 | FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM) | GEX | 2007-05-17 | 108 |
| K063808 | FRAXEL IV SR LASER SYSTEM | GEX | 2007-04-27 | 126 |
| K063038 | FRAXEL III SR LASER SYSTEM AND ACCESSORIES | GEX | 2007-04-27 | 207 |
| K062303 | FRAXEL II SR LASER SYSTEM | GEX | 2007-01-31 | 176 |
| K060310 | FRAXEL II SR LASER SYSTEM AND ACCESSORIES | GEX | 2006-03-29 | 50 |
| K053047 | FRAXEL SR LASER SYSTEM | GEX | 2006-03-20 | 143 |
| K050841 | FRAXEL SR LASER SYSTEM | GEX | 2005-07-05 | 95 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Reliant Technologies, 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.
- Reliant Laser Corp. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Reliant Technologies, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Reliant Technologies, Inc.” (first 1994, latest 2008), across 2 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 Reliant Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Reliant Technologies, Inc. is 153 days.
Which FDA product codes appear under Reliant Technologies, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 18); IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat, 1).
Next steps
- See all 19 Reliant Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Reliant Technologies, 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.