KOLBERG OPHTHALMIC CONFORMER
Device Facts
| Record ID | K945110 |
|---|---|
| Device Name | KOLBERG OPHTHALMIC CONFORMER |
| Applicant | Kolberg Ocular Products, Inc. |
| Product Code | HQN · Ophthalmic |
| Decision Date | Jan 13, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.3130 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
