Product code MOE
- Device name
- Collagen Corneal Shield
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4750
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K944872 | BIO-COR COLLAGEN CORNEAL SHIELD | Bausch & Lomb Healthcare and Optics Worldwide | 1995-07-26 |
| K915861 | MEDILENS-CS CORNEAL SHIELD | Chiron Ophthalmics | 1992-03-06 |
| K914529 | SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS | Oasis Medical, Inc. | 1991-11-13 |
| K913148 | COLLAGEN SHIELD FOR ACUTE CARE | Vitaphore Corp. | 1991-10-15 |
| K905825 | COLLAGEN SHIELD, VARIOUS MODELS | Chiron Ophthalmics | 1991-06-10 |
| K902558 | COLLAGEN SHIELD FOR ACUTE CARE | Vitaphore Corp. | 1990-08-17 |
| K901880 | MEDILENS(TM) CORNEAL SHIELD | Chiron Ophthalmics | 1990-07-02 |
| K896449 | IM COLLAGEN SHIELD | Intermedical, Inc. | 1990-05-24 |
| K884962 | ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA | Bausch & Lomb Pharmaceutical, Inc. | 1990-02-09 |
| K885015 | COI 72 HR COLLAGEN SHIELD | Chiron Ophthalmics | 1989-06-23 |
| K884961 | ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1989-02-13 |
| K884960 | ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1989-02-13 |
| K885016 | COI 24 HR COLLAGEN SHIELD | Chiron Ophthalmics | 1989-02-01 |
| K884364 | LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1988-11-29 |
| K884363 | LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1988-11-29 |
| K882762 | COLLAGEN SHIELD | Chiron Ophthalmics | 1988-09-12 |
| K874225 | BIO-COR EXT COLLAGEN CORNEAL SHIELD | Bausch & Lomb, Inc. | 1988-01-22 |
| K874224 | BIO-COR II COLLAGEN CORNEAL SHIELD | Bausch & Lomb, Inc. | 1988-01-22 |
| K862315 | FYODOROV COLLAGEN CORNEAL SHIELD | Medical Technology Development Corp. | 1987-01-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00845819005705 | SOFT SHIELD® Collagen Shields | OASIS MEDICAL, INC. | 2023-06-30 |
| 00845819005699 | SOFT SHIELD® Collagen Shields | OASIS MEDICAL, INC. | 2023-06-30 |
| 10845819005795 | SOFT SHIELD® Collagen Shields | OASIS MEDICAL, INC. | 2023-06-30 |
| 10845819005788 | SOFT SHIELD® Collagen Shields | OASIS MEDICAL, INC. | 2023-06-30 |
| 10845819005771 | SOFT SHIELD® Collagen Shields | OASIS MEDICAL, INC. | 2023-06-30 |
| 10845819005702 | SOFT SHIELD® Collagen Shields | OASIS MEDICAL, INC. | 2023-06-30 |
| 10845819005696 | SOFT SHIELD® Collagen Shields | OASIS MEDICAL, INC. | 2023-06-30 |
| 00845819005798 | SOFT SHIELD® Collagen Shields | OASIS MEDICAL, INC. | 2023-06-30 |
| 00845819005781 | SOFT SHIELD® Collagen Shields | OASIS MEDICAL, INC. | 2023-06-30 |
| 00845819005774 | SOFT SHIELD® Collagen Shields | OASIS MEDICAL, INC. | 2023-06-30 |
| 00192896109773 | Cox II H Eye Shield | SONTEC INSTRUMENTS, INC. | 2021-05-13 |
| 00192896109780 | Cox II H Eye Shield | SONTEC INSTRUMENTS, INC. | 2021-05-13 |
| 00192896103382 | Eye Shield | SONTEC INSTRUMENTS, INC. | 2020-07-13 |
| 00192896103399 | Eye Shield | SONTEC INSTRUMENTS, INC. | 2020-07-13 |
| 00192896095342 | OCULAR SHIELD | SONTEC INSTRUMENTS, INC. | 2019-03-07 |
| 00192896095267 | OCULAR SHIELD | SONTEC INSTRUMENTS, INC. | 2019-03-07 |
| 00192896095335 | OCULAR SHIELD | SONTEC INSTRUMENTS, INC. | 2019-03-07 |
| 00192896095328 | OCULAR SHIELD | SONTEC INSTRUMENTS, INC. | 2019-03-07 |
| 00192896095311 | OCULAR SHIELD | SONTEC INSTRUMENTS, INC. | 2019-03-07 |
| 00192896095304 | OCULAR SHIELD | SONTEC INSTRUMENTS, INC. | 2019-03-07 |
| 00192896095298 | OCULAR SHIELD | SONTEC INSTRUMENTS, INC. | 2019-03-07 |
| 00192896095281 | OCULAR SHIELD | SONTEC INSTRUMENTS, INC. | 2019-03-07 |
| 00192896095274 | OCULAR SHIELD | SONTEC INSTRUMENTS, INC. | 2019-03-07 |
| 00192896095250 | OCULAR SHIELD | SONTEC INSTRUMENTS, INC. | 2019-03-07 |
| 00192896047426 | CORNEAL EYE SHIELD | SONTEC INSTRUMENTS, INC. | 2018-09-17 |
| 00192896047433 | CORNEAL EYE SHIELD | SONTEC INSTRUMENTS, INC. | 2018-09-17 |
| 00192896047457 | CORNEAL EYE SHIELD | SONTEC INSTRUMENTS, INC. | 2018-09-17 |
| 00192896047464 | CORNEAL EYE SHIELD | SONTEC INSTRUMENTS, INC. | 2018-09-17 |
| 00192896047488 | CORNEAL EYE SHIELD | SONTEC INSTRUMENTS, INC. | 2018-09-17 |
| 00192896047501 | CORNEAL EYE SHIELD | SONTEC INSTRUMENTS, INC. | 2018-09-17 |