HQJ · Implant, Absorbable, (Scleral Buckling Methods)
Ophthalmic · 21 CFR 886.3300 · Class 2
Overview
| Product Code | HQJ |
|---|---|
| Device Name | Implant, Absorbable, (Scleral Buckling Methods) |
| Regulation | 21 CFR 886.3300 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| Implant | Yes |
Identification
An absorbable implant (scleral buckling method) is a device intended to be implanted on the sclera to aid retinal reattachment.
Classification Rationale
Class II.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K896350 | TITAN AIR SPECTACLE FRAME | Acces Intl. Eyewear | Dec 18, 1989 | SESE |
| K884362 | LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD | Bausch & Lomb Pharmaceutical, Inc. | Nov 29, 1988 | SESE |
| K875014 | LABTICIAN RETINAL IMPLANTS | Labtician Products, Inc. | Feb 26, 1988 | SESE |
| K831773 | MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK | Bcd Products, Inc. | Aug 16, 1983 | SESE |
| K760550 | IMPLANT, SILICONE AND TANTALUM | Medical Instrument Research Assoc., Inc. | Oct 5, 1976 | SESE |
Top Applicants
- Acces Intl. Eyewear — 1 clearance
- Bausch & Lomb Pharmaceutical, Inc. — 1 clearance
- Bcd Products, Inc. — 1 clearance
- Labtician Products, Inc. — 1 clearance
- Medical Instrument Research Assoc., Inc. — 1 clearance
