FDA Registration
Active
🇺🇸 United States
FOCUS MEDICAL, LLC.
Reg #: 1226486
·
FEI: 3003067608
·
Expires 2026
Products
6
Proprietary Names
24
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- FOCUS MEDICAL, LLC.
- Registration Number
- 1226486
- FEI Number
- 3003067608
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 23 FRANCIS J. CLARKE CIRCLE
- City
- Bethel
- State
- CT
- ZIP
- 06801
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151473
Owner / Operator
- Firm Name
- FOCUS MEDICAL, LLC.
- Operator Number
- 9041937
- Address
- 23 FRANCIS J. CLARKE CIRCLE, --
- City
- Bethel
- State
- CT
- Postal Code
- 06801
- Country
- US
- Correspondent
- JOHN B LEE, JR.
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2015-09-16 |
| Laser Assisted Lipolysis | ORK | Class 2 | General, Plastic Surgery | No | 2010-09-01 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2022-04-06 |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | Class 2 | General, Plastic Surgery | No | 2012-12-26 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2010-09-01 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2001-07-25 |
Proprietary Names
PiQo
NaturaLase PiQo
PiQo4
NaturaLase 1064
NaturaLase 2J
LT100A
NaturaLase QS
LT100
NaturaLase 980
NaturaLight
Carbon Wave Patch
NaturaLase Er+
NaturaLase LTE
NaturaLase
NaturaLase Er with microHEX
NaturaLase Er
NaturaLase Dye Pack Accessory
NaturaLase 532 Adaptor
LT 100-A
Solaria
NaturaLase CO2
LPY
NaturaLase LP
MiniDerm
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility