Contract manufacturerPRECISION OPTICS CORP. (Gardner, MA)MassachusettsEar, nose and throatGastroenterology and urologyGeneral and plastic surgeryNeurologyOphthalmicCardiovascularClass IClass IIClass III
PRECISION OPTICS CORP.
Contract manufacturer · Gardner, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1222616 (openFDA record; or search FDA's registration database)
- FEI number
- 1000120916
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- PRECISION OPTICS CORP. (FDA owner/operator no. 9001379)
- Registered address
- 22 E Broadway, Gardner, MA 01440
- Contract listings
- 8 device listings, 9 product codes, first listed Mar 19, 1996
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| EQL | Laryngostroboscope | Class I | Ear, nose and throat | Contract manufacturing | Mar 15, 2011 |
| ERA | Otoscope | Class I | Ear, nose and throat | Contract manufacturing | Sep 21, 1998 |
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | Class I | Gastroenterology and urology | Contract manufacturing | Mar 19, 1996 |
| FSQ | Light, Surgical, Instrument | Class II | General and plastic surgery | Contract manufacturing | Jan 22, 2013 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | Class II | Neurology | Contract manufacturing | Jan 22, 2013 |
| HKI | Camera, Ophthalmic, Ac-Powered | Class II | Ophthalmic | Contract manufacturing | Mar 30, 2026 |
| HQF | Laser, Ophthalmic | Class II | Ophthalmic | Contract manufacturing | May 19, 2025 |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Class III | Cardiovascular | Contract manufacturing | Jul 13, 2017 |
| PZP | Fluid Jet Removal System | Class II | General and plastic surgery | Contract manufacturing | Mar 30, 2026 |