MOE · Collagen Corneal Shield
Ophthalmic · 21 CFR 886.4750 · Class 1
Overview
| Product Code | MOE |
|---|---|
| Device Name | Collagen Corneal Shield |
| Regulation | 21 CFR 886.4750 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.
Classification Rationale
Class I (general controls). When made only of plastic or aluminum, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. When made only of plastic or aluminum, the devices are exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Cleared Devices (19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K944872 | BIO-COR COLLAGEN CORNEAL SHIELD | Bausch & Lomb Healthcare and Optics Worldwide | Jul 26, 1995 | SESE |
| K915861 | MEDILENS-CS CORNEAL SHIELD | Chiron Ophthalmics | Mar 6, 1992 | SESE |
| K914529 | SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS | Oasis Medical, Inc. | Nov 13, 1991 | SESE |
| K913148 | COLLAGEN SHIELD FOR ACUTE CARE | Vitaphore Corp. | Oct 15, 1991 | SESE |
| K905825 | COLLAGEN SHIELD, VARIOUS MODELS | Chiron Ophthalmics | Jun 10, 1991 | SESE |
| K902558 | COLLAGEN SHIELD FOR ACUTE CARE | Vitaphore Corp. | Aug 17, 1990 | SESE |
| K901880 | MEDILENS(TM) CORNEAL SHIELD | Chiron Ophthalmics | Jul 2, 1990 | SESE |
| K896449 | IM COLLAGEN SHIELD | Intermedical, Inc. | May 24, 1990 | SESE |
| K884962 | ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA | Bausch & Lomb Pharmaceutical, Inc. | Feb 9, 1990 | SESE |
| K885015 | COI 72 HR COLLAGEN SHIELD | Chiron Ophthalmics | Jun 23, 1989 | SESE |
| K884961 | ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | Feb 13, 1989 | SESE |
| K884960 | ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | Feb 13, 1989 | SESE |
| K885016 | COI 24 HR COLLAGEN SHIELD | Chiron Ophthalmics | Feb 1, 1989 | SESE |
| K884364 | LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | Nov 29, 1988 | SESE |
| K884363 | LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | Nov 29, 1988 | SESE |
| K882762 | COLLAGEN SHIELD | Chiron Ophthalmics | Sep 12, 1988 | SESE |
| K874225 | BIO-COR EXT COLLAGEN CORNEAL SHIELD | Bausch & Lomb, Inc. | Jan 22, 1988 | SESE |
| K874224 | BIO-COR II COLLAGEN CORNEAL SHIELD | Bausch & Lomb, Inc. | Jan 22, 1988 | SESE |
| K862315 | FYODOROV COLLAGEN CORNEAL SHIELD | Medical Technology Development Corp. | Jan 7, 1987 | SESE |
Top Applicants
- Chiron Ophthalmics — 6 clearances
- Bausch & Lomb Pharmaceutical, Inc. — 5 clearances
- Vitaphore Corp. — 2 clearances
- Bausch & Lomb, Inc. — 2 clearances
- Oasis Medical, Inc. — 1 clearance
