Solid Dilicone Implants, Sdilicone Sponge Implants
FDA 510(k) K950806 · Mira, Inc.
510(k) numberK950806
Submission
- Device name
- Solid Dilicone Implants, Sdilicone Sponge Implants
- Applicant
- Mira, Inc.
Uxbridge, MA, US - Received
- February 22, 1995
- Decision date
- June 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQX – Implant, Orbital, Extra-Ocular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3340
- Specialty
- Ophthalmic
- Implant
- Yes
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|---|---|---|---|
| K023481 | Microvision Scleral Buckling ComponentsHQX · Traditional | Microvision, Inc. | 01/08/2003SE |
| K983581 | Ocu-Guard and Ocu-Guard SuppleHQX · Special | Bio-Vascular, Inc. | 11/06/1998SE |
| K980816 | Retinal Detachment Implants, Including Bands, Strips (Rails) and SpongesHQX · Traditional | Fci Ophthalmics, Inc. | 09/18/1998SE |
| K963219 | Retinal Detachment Implants; Including Bans, Strips, Tires, Sleeves, Cords and SpongesHQX · Traditional | Fci Ophthalmics, Inc. | 10/28/1996SE |
| K950599 | Stors Scleral Sponge II (Lincoff Design)HQX · Traditional | Storz Ophthalmics, Inc. | 03/02/1995SE |
| K945172 | Visitec Silicone Retinal Implants/ExplantsHQX · Traditional | Visitec Co. | 01/17/1995SE |
| K902308 | Tamcenan Ocular Explants and BandsHQX · Traditional | Tamcenan Corp. | 06/19/1990SE |
| K901002 | O'Donnell, Socket Reconstruction ProsthesesHQX · Traditional | Oculo Plastik, Inc. | 05/22/1990SE |
| K900929 | Putterman-Scott, Socket Reconstruction BilateralHQX · Traditional | Oculo Plastik, Inc. | 05/18/1990SE |
| K900930 | Spivey-Allen Orbital Floor ImplantHQX · Traditional | Oculo Plastik, Inc. | 05/15/1990SE |
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| K933527 | Modification of Anterior Segment ElectrodesHWA · Traditional | 01/25/1994SE |
| K923629 | Ophthalmic Trichiasis ProbeHPS · Traditional | 10/19/1992SE |
| K894248 | Converter SystemHQE · Traditional | 02/27/1990SE |
| K891601 | Power Operated and Controlled Vitreous ScissorsHQE · Traditional | 05/23/1989SE |
| K890448 | Light Source, Endoscop, Xenon ArcFFS · Traditional | 05/08/1989SE |
| K863246 | MiraliteHQF · Traditional | 10/31/1986SE |
| K863591 | Endophotocoagulation ProbeHQF · Traditional | 10/10/1986SE |
| K855105 | Simmons ShellHQT · Traditional | 03/31/1986SE |
Questions and answers
When was Solid Dilicone Implants, Sdilicone Sponge Implants cleared by the FDA?
Solid Dilicone Implants, Sdilicone Sponge Implants (K950806) received a 510(k) decision of Substantially Equivalent on June 5, 1996, 469 days after the submission was received.
What is the product code of K950806?
The FDA product code is HQX – Implant, Orbital, Extra-Ocular, a Class II (moderate risk) device regulated under 21 CFR 886.3340.