Collagen Corneal Shield
The Collagen Corneal Shield is an ophthalmic device made from collagen that is applied to the surface of the cornea to protect it during healing after surgery or injury, while also serving as a vehicle for drug delivery to the eye. Classified as FDA Class 1 under 21 CFR 886.4750 in the Ophthalmic specialty, it is GMP-exempt and 510(k)-exempt, subject only to general controls. The product code is MOE.
Research product code MOE in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- MOE
- Device Class
- FDA class 1
- Regulation Number
- 886.4750
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 19 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K944872 | BIO-COR COLLAGEN CORNEAL SHIELD | Jul 26, 1995 | Substantially Equivalent | Bausch & Lomb Healthcare and Optics Worldwide |
| K915861 | MEDILENS-CS CORNEAL SHIELD | Mar 06, 1992 | Substantially Equivalent | Chiron Ophthalmics |
| K914529 | SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS | Nov 13, 1991 | Substantially Equivalent | Oasis Medical, Inc. |
| K913148 | COLLAGEN SHIELD FOR ACUTE CARE | Oct 15, 1991 | Substantially Equivalent | Vitaphore Corp. |
| K905825 | COLLAGEN SHIELD, VARIOUS MODELS | Jun 10, 1991 | Substantially Equivalent | Chiron Ophthalmics |
| K902558 | COLLAGEN SHIELD FOR ACUTE CARE | Aug 17, 1990 | Substantially Equivalent | Vitaphore Corp. |
| K901880 | MEDILENS(TM) CORNEAL SHIELD | Jul 02, 1990 | Substantially Equivalent | Chiron Ophthalmics |
| K896449 | IM COLLAGEN SHIELD | May 24, 1990 | Substantially Equivalent | Intermedical, Inc. |
| K884962 | ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA | Feb 09, 1990 | Substantially Equivalent | Bausch & Lomb Pharmaceutical, Inc. |
| K885015 | COI 72 HR COLLAGEN SHIELD | Jun 23, 1989 | Substantially Equivalent | Chiron Ophthalmics |
| K884961 | ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL | Feb 13, 1989 | Substantially Equivalent | Bausch & Lomb Pharmaceutical, Inc. |
| K884960 | ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL | Feb 13, 1989 | Substantially Equivalent | Bausch & Lomb Pharmaceutical, Inc. |
| K885016 | COI 24 HR COLLAGEN SHIELD | Feb 01, 1989 | Substantially Equivalent | Chiron Ophthalmics |
| K884364 | LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL | Nov 29, 1988 | Substantially Equivalent | Bausch & Lomb Pharmaceutical, Inc. |
| K884363 | LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL | Nov 29, 1988 | Substantially Equivalent | Bausch & Lomb Pharmaceutical, Inc. |
| K882762 | COLLAGEN SHIELD | Sep 12, 1988 | Substantially Equivalent | Chiron Ophthalmics |
| K874225 | BIO-COR EXT COLLAGEN CORNEAL SHIELD | Jan 22, 1988 | Substantially Equivalent | Bausch & Lomb, Inc. |
| K874224 | BIO-COR II COLLAGEN CORNEAL SHIELD | Jan 22, 1988 | Substantially Equivalent | Bausch & Lomb, Inc. |
| K862315 | FYODOROV COLLAGEN CORNEAL SHIELD | Jan 07, 1987 | Substantially Equivalent | Medical Technology Development Corp. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.