Eye Spheres
FDA 510(k) K082850 · Product and Educational Services, LLC
510(k) numberK082850
Submission
- Device name
- Eye Spheres
- Applicant
- Product and Educational Services, LLC
Doylestown, PA, US - Received
- September 29, 2008
- Decision date
- February 27, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HPZ – Implant, Eye Sphere
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3320
- Specialty
- Ophthalmic
- Implant
- Yes
Other 510(k)s with product code HPZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212741 | EzyporHPZ · Traditional | Fci (France Chirurgie Instrumentation) Sas | 06/24/2022SE |
| K123764 | Durette Ocular ImplantHPZ · Traditional | Oculo-Plastik, Inc. | 01/31/2013SE |
| K110554 | Bioceramic Orbital Implant, OrbtexHPZ · Traditional | Ceramisys, Ltd. | 11/02/2011SE |
| K112176 | Silicone SpheresHPZ · Special | Oculo Plastik, Inc. | 09/15/2011SE |
| K083342 | Orbital Reconstructive Implant IIHPZ · Traditional | Evera Medical, Inc. | 03/12/2009SE |
| K073293 | Durette ImplantHPZ · Traditional | Oculo Plastik, Inc. | 03/19/2008SE |
| K071335 | Medpor Attractor ImplantHPZ · Traditional | Porex Surgical, Inc. | 08/08/2007SE |
| K070130 | Orbital Reconstructive ImplantHPZ · Traditional | Becker & Associates Consulting, Inc. | 04/19/2007SE |
| K053298 | Alphasphere Orbital ImplantHPZ · Traditional | Hydron Pty Limited | 05/09/2006SE |
| K040851 | Medpor Attractor Magnetic Coupling SystemHPZ · Traditional | Porex Surgical, Inc. | 07/16/2004SE |
Questions and answers
When was Eye Spheres cleared by the FDA?
Eye Spheres (K082850) received a 510(k) decision of Substantially Equivalent on February 27, 2009, 151 days after the submission was received.
What is the product code of K082850?
The FDA product code is HPZ – Implant, Eye Sphere, a Class II (moderate risk) device regulated under 21 CFR 886.3320.