Led Technologies, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Led Technologies, Inc.” (first 2008, latest 2022), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 104 days. Since 2017 the median was 89 days, against 91 days for all cleared 510(k)s in the same product codes. 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 | 1 | 328 |
| 2016 | 0 | — |
| 2017 | 2 | 86 |
| 2018 | 4 | 94 |
| 2019 | 2 | 102 |
| 2020 | 0 | — |
| 2021 | 2 | 262 |
| 2022 | 2 | 52 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Led Technologies, Inc. took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OHS | Light Based Over The Counter Wrinkle Reduction | 11 | 11 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 3 | 3 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
Review panels
Most recent Led Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223482 | reVive Light Therapy® Wrinkle and Acne LED Device | OHS | 2022-12-21 | 33 |
| K221430 | reVive Light Therapy LED Cleansing System | OHS | 2022-07-27 | 71 |
| K210968 | reVive Light Therapy Essentials | OLP | 2021-12-21 | 265 |
| K210965 | reVive Light Therapy Essentials | OHS | 2021-12-15 | 259 |
| K183247 | dpl Faceware | OHS | 2019-03-14 | 113 |
| K183118 | dpl SpotLite | OLP | 2019-02-07 | 90 |
| K180447 | reVive Light Therapy LED Cleansing System | OLP | 2018-06-04 | 104 |
| K180445 | reVive Light Therapy LED Ultrasonic Wrinkle System | OHS | 2018-05-15 | 84 |
| K180320 | dpl IIa Panel | OHS | 2018-04-03 | 57 |
| K172662 | reVive Perioral | OHS | 2018-01-09 | 126 |
5 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-03-30.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Led Technologies, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Led Technologies, Inc.” (first 2008, latest 2022), across 3 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 Led Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Led Technologies, Inc. is 104 days. Since 2017: 89 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Led Technologies, Inc.?
The most frequent FDA product codes under this applicant name are OHS (Light Based Over The Counter Wrinkle Reduction, 11); OLP (Over-The-Counter Powered Light Based Laser For Acne, 3); ILY (Lamp, Infrared, Therapeutic Heating, 1).
Next steps
- See all 15 Led Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OHS, Led 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.