Focus Medical, LLC.
Bethel, CT, US
FOCUS MEDICAL, LLC. appears in FDA device records in Bethel, CT. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Focus Medical, LLC. between 1997 and 2016. The busiest year on record is 2004, with 2. The most recent is 2016, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 2000 | 1 |
| 2003 | 1 |
| 2004 | 2 |
| 2010 | 1 |
| 2012 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K152737 | Lite Touch | GEX | Substantially Equivalent | |
| K152529 | NaturaLase CO2 Laser System | GEX | Substantially Equivalent | |
| K151473 | NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module | GEX | Substantially Equivalent | |
| K110333 | NATURALASE CO2 LASER SYSTEM | ONG | Substantially Equivalent | |
| K101152 | NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810 | GEX | Substantially Equivalent | |
| K041829 | FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS | GEX | Substantially Equivalent | |
| K032667 | FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW) | GEX | Substantially Equivalent | |
| K031828 | NATURALASE LP ND:YAG LASER | GEN | Substantially Equivalent | |
| K992597 | LORAD LT-100 LASER TREATMENT SYSTEM | GEX | Substantially Equivalent | |
| K970970 | CARDIOMATCH | KPS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1226486 | 3003067608 | FOCUS MEDICAL, LLC. | 23 FRANCIS J. CLARKE CIRCLE, Bethel, CT 06801 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- GENForceps, General & Plastic Surgery
- ORKLaser Assisted Lipolysis
- GEYMotor, Surgical Instrument, Ac-Powered
- GEXPowered Laser Surgical Instrument
- ONGPowered Laser Surgical Instrument With MicrobeamFractional Output
- KPSSystem, Tomography, Computed, Emission
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain