Lexington International, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Lexington International, LLC” (first 2007, latest 2018), across 1 product code in 1 review panel. Median 510(k) review time under this name: 78 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 | 1 | 80 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 77 |
| 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, 510(k)s cleared under the name Lexington International, LLC took a median 77 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OAP | Laser, Comb, Hair | 8 | 8 |
Review panels
Most recent Lexington International, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180885 | HairMax Laser | OAP | 2018-06-20 | 77 |
| K142573 | HairMax LaserComb, HairMax LaserComb | OAP | 2014-12-01 | 80 |
| K112524 | HAIRMAX LASERCOMB | OAP | 2011-09-26 | 26 |
| K111714 | HAIRMAX DUAL 12 | OAP | 2011-08-16 | 57 |
| K110233 | HAIRMAX LASERCOMB | OAP | 2011-05-27 | 121 |
| K103368 | HAIRMAX LASERCOMB | OAP | 2011-04-06 | 140 |
| K093499 | HAIRMAX LASERCOMB | OAP | 2009-11-23 | 11 |
| K060305 | HAIRMAX LASERCOMB | OAP | 2007-01-18 | 346 |
Recalls
openFDA lists no recalls under a recalling firm named Lexington International, LLC.
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.
Device clinical trials
An industry sponsor named Lexington International, LLC is the lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01016964: Treatment of Androgenetic Alopecia in Females, 12 Beam (Completed, started 2010-01)
- NCT00981461: Treatment of Androgenetic Alopecia in Females, 9 Beam (Completed, started 2009-10)
- NCT00947505: Treatment of Androgenetic Alopecia in Males (Completed, started 2009-08)
- NCT00947219: Treatment of Androgenic Alopecia in Males (Completed, started 2009-07)
- NCT00830908: HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis (Completed, started 2009-01)
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.
- Lexington Medical, Inc. (9 510(k)s)
- Lexington Industries (2 510(k)s)
- Lexington Instruments (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lexington International, LLC?
FDA lists 8 510(k) clearances under the applicant name “Lexington International, LLC” (first 2007, latest 2018), 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 Lexington International, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lexington International, LLC is 78 days.
Which FDA product codes appear under Lexington International, LLC?
The most frequent FDA product codes under this applicant name are OAP (Laser, Comb, Hair, 8).
Next steps
- See all 8 Lexington International, LLC clearances with predicates and recalls
- Run predicate analysis for product code OAP, Lexington International, LLC'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.