FDA Registration
Active
🇺🇸 United States
OPTIM LLC
Reg #: 1218141
·
FEI: 1218141
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
3
Classifications
3
Registration Details
- Registration Name
- OPTIM LLC
- Registration Number
- 1218141
- FEI Number
- 1218141
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 64 TECHNOLOGY PARK RD.
- City
- Sturbridge
- State
- MA
- ZIP
- 01566
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091829
Owner / Operator
- Firm Name
- OPTIM LLC
- Operator Number
- 1218141
- Address
- 64 TECHNOLOGY PARK RD., --
- City
- Sturbridge
- State
- MA
- Postal Code
- 01566
- Country
- US
- Correspondent
- Clifford Kites
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2009-07-29 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2008-04-04 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2016-11-14 |
Proprietary Names
Portable Light Source
ENTity
Vidcap Camera Kit
ENT 3.6FP
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility