Product code HQJ
- Device name
- Implant, Absorbable, (Scleral Buckling Methods)
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.3300
- Review panel
- OP
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K896350 | TITAN AIR SPECTACLE FRAME | Acces Intl. Eyewear | 1989-12-18 |
| K884362 | LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD | Bausch & Lomb Pharmaceutical, Inc. | 1988-11-29 |
| K875014 | LABTICIAN RETINAL IMPLANTS | Labtician Products, Inc. | 1988-02-26 |
| K831773 | MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK | Bcd Products, Inc. | 1983-08-16 |
| K760550 | IMPLANT, SILICONE AND TANTALUM | Medical Instrument Research Assoc., Inc. | 1976-10-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10871321001666 | 2.5mm Circling Band | Labtician Ophthalmics, Inc | 2018-02-22 |
| 10871321001710 | 2.5mm Grooved Strip | Labtician Ophthalmics, Inc | 2018-02-22 |
| 10871321001765 | Silicone Tire 10mm LG | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001901 | Meridional Implant | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001895 | Silicone Sleeve | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001888 | Silicone Sleeve | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001871 | Silicone Tire | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001864 | Silicone Tire 10mm | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001857 | Silicone Tire 7mm WG | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001840 | Silicone Tire 7mm | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001833 | Silicone Strip | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001826 | Boat | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001819 | Silicone Tire 6mm | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001802 | Silicone Tire 9mm | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001796 | Silicone Tire 7.0mm | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001789 | Silicone Strip | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001772 | Silicone Tire 12.5mm | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001758 | Silicone Tire 10mm | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001741 | Silicone Tire 8.5mm | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001734 | Silicone Tire 6.0mm | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001727 | Pad | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001703 | Silicone Strip | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001697 | Silicone Tire 9mm | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001680 | Boat | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001673 | Meridional Implant | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001659 | Circling Band | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001642 | Silicone Tire 7mm | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001635 | Meridional Implant - Flat | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001628 | Silicone Tire 10mm | Labtician Ophthalmics, Inc | 2015-10-09 |
| 10871321001369 | Grooved Sponge | Labtician Ophthalmics, Inc | 2015-10-05 |