Lares Research, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Lares Research, Inc.” (first 1991, latest 2022), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 130 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 | 169 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 246 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Lares Research, Inc. took a median 246 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | 4 | 4 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 1 |
Review panels
Most recent Lares Research, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220873 | Perceptive electric dental motor and control unit | EIA | 2022-12-15 | 265 |
| K220874 | Smooth Drive contra angle and straight handpieces | EGS | 2022-11-07 | 227 |
| K141221 | LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR | EFB | 2014-10-28 | 169 |
| K031540 | APEX ELECTRIC HANDPIECE SYSTEM | EKX | 2003-06-30 | 45 |
| K011960 | LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4) | GEX | 2001-12-21 | 182 |
| K983524 | LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP) | GEX | 1999-04-01 | 175 |
| K961163 | LARES RESEARCH AS-1 LOWSPEED HANDPIECE | EFB | 1996-04-23 | 32 |
| K905543 | LARES APOLLO CS/CP/C | EBZ | 1991-03-11 | 90 |
| K905542 | LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS | EFB | 1991-03-11 | 90 |
| K905541 | LARES 757 WORKHORSE HIGHSPEED HANDPIECE | EFB | 1991-03-07 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Lares Research, 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.
- Lares Manufacturing Co., Inc. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lares Research, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Lares Research, Inc.” (first 1991, latest 2022), across 6 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 Lares Research, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lares Research, Inc. is 130 days.
Which FDA product codes appear under Lares Research, Inc.?
The most frequent FDA product codes under this applicant name are EFB (Handpiece, Air-Powered, Dental, 4); GEX (Powered Laser Surgical Instrument, 2); EBZ (Activator, Ultraviolet, For Polymerization, 1).
Next steps
- See all 10 Lares Research, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EFB, Lares Research, 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.