FDA Registration
Active
🇺🇸 United States
PRECISION OPTICS CORP.
Reg #: 1222616
·
FEI: 1000120916
·
Expires 2026
Products
9
Proprietary Names
8
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- PRECISION OPTICS CORP.
- Registration Number
- 1222616
- FEI Number
- 1000120916
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 22 E Broadway
- City
- GARDNER
- State
- MA
- ZIP
- 01440
- Country
- US
Owner / Operator
- Firm Name
- PRECISION OPTICS CORP.
- Operator Number
- 9001379
- Address
- 22 EAST BROADWAY, --
- City
- Gardner
- State
- MA
- Postal Code
- 01440
- Country
- US
- Correspondent
- Troy Evangelista
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2017-07-13 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2026-03-30 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 1998-09-21 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2013-01-22 |
| Light, Surgical, Instrument | FSQ | Class 2 | General, Plastic Surgery | No | 2013-01-22 |
| Fluid Jet Removal System | PZP | Class 2 | General, Plastic Surgery | No | 2026-03-30 |
| Laryngostroboscope | EQL | Class 1 | Ear, Nose, Throat | No | 2011-03-15 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2025-05-19 |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 1996-03-19 |
Proprietary Names
Heartlight System
RetCam Envision
Otoscan
Spotlight Access System
Hydros Robotic System
Laryngostroboscope
Leos Laser and Endoscopy System
Zoom Coupler
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)