VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
Device Facts
| Record ID | K945172 |
|---|---|
| Device Name | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS |
| Applicant | Visitec Co. |
| Product Code | HQX · Ophthalmic |
| Decision Date | Jan 17, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.3340 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.
