Focus Medical, LLC: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Focus Medical, LLC” (first 2000, latest 2016), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 148 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 | 1 | 434 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 92 |
| 2016 | 2 | 217 |
| 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 | 7 | 7 |
| GEN | Forceps, General & Plastic Surgery | 1 | 1 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | 1 | 1 |
Review panels
Most recent Focus Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152737 | Lite Touch | GEX | 2016-06-29 | 280 |
| K152529 | NaturaLase CO2 Laser System | GEX | 2016-02-04 | 154 |
| K151473 | NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module | GEX | 2015-09-01 | 92 |
| K110333 | NATURALASE CO2 LASER SYSTEM | ONG | 2012-04-12 | 434 |
| K101152 | NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810 | GEX | 2010-08-18 | 117 |
| K041829 | FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS | GEX | 2004-09-07 | 62 |
| K032667 | FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW) | GEX | 2004-01-23 | 148 |
| K031828 | NATURALASE LP ND:YAG LASER | GEN | 2003-07-17 | 34 |
| K992597 | LORAD LT-100 LASER TREATMENT SYSTEM | GEX | 2000-04-24 | 265 |
Recalls
openFDA lists no recalls under a recalling firm named Focus Medical, 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 Focus Medical, LLC is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04214873: Evaluation of the Effectiveness of the PiQo4 System for Reduction of Infra-orbital Pigmentation (Completed, started 2020-01-06)
- NCT03565341: Efficacy and Safety of PiQo4 Device for Treatment of Melasma (Completed, started 2018-07-02)
- NCT03565146: Evaluation of the Efficacy and Safety of PiQo4 System for the Treatment of Pigmented Lesions (Completed, started 2018-06-29)
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.
- Focus Diagnostics, Inc. (16 510(k)s)
- Focus Technologies, Inc. (5 510(k)s)
- Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC (1 510(k)s)
- Focus International, Inc. (1 510(k)s)
- Focus Medical SA (1 510(k)s)
- Focus Surgery, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Focus Medical, LLC?
FDA lists 9 510(k) clearances under the applicant name “Focus Medical, LLC” (first 2000, latest 2016), across 3 product codes 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 Focus Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Focus Medical, LLC is 148 days.
Which FDA product codes appear under Focus Medical, LLC?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 7); GEN (Forceps, General & Plastic Surgery, 1); ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output, 1).
Next steps
- See all 9 Focus Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code GEX, Focus Medical, 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.