Litecure, LLC: FDA clearances and approvals
Litecure, LLC has 7 FDA 510(k) clearances (first 2007, latest 2018), across 3 product codes in 2 review panels. Median 510(k) review time: 66 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 46 |
| 2013 | 1 | 183 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 146 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Litecure, LLC's cleared 510(k)s took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
| ILY | Lamp, Infrared, Therapeutic Heating | 3 | 3 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | 1 | 1 |
Review panels
Most recent Litecure, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173067 | LightForce LTS Model 1000, 1500, 2500, and 4000 | GEX | 2018-02-22 | 146 |
| K123014 | LITECURE THERAPY SYSTEM MODEL LTS-1500 | PDZ | 2013-03-29 | 183 |
| K123031 | BWF-5 MEDICAL LASER SERIES | GEX | 2012-12-03 | 66 |
| K121487 | LITECURE THERAPY COMPACT | ILY | 2012-06-12 | 25 |
| K103511 | LITECURE THERAPY SYSTEM | ILY | 2011-01-25 | 56 |
| K093087 | BWF-5 MEDICAL LASER SERIES | GEX | 2010-05-12 | 223 |
| K070400 | LC THERAPY, MODEL LCT-1000 | ILY | 2007-02-28 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Litecure, LLC.
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 Litecure, LLC have?
Litecure, LLC has 7 FDA 510(k) clearances (first 2007, latest 2018), across 3 product codes in 2 review panels.
How long does FDA take to clear Litecure, LLC's 510(k)s?
The median time from FDA receipt to decision across Litecure, LLC's cleared 510(k)s is 66 days.
What devices does Litecure, LLC make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 3); ILY (Lamp, Infrared, Therapeutic Heating, 3); PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis, 1).
Has Litecure, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Litecure, LLC. Related entities may recall under other names.
Next steps
- See all 7 Litecure, LLC clearances with predicates and recalls
- Run predicate analysis for product code GEX, Litecure, LLC'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.