510(k) K032104
K032104 is an FDA 510(k) premarket notification submitted by Bio-Tissue, Inc. for the device "AMNIOLENS". The FDA issued a decision of Substantially Equivalent on December 12, 2003. The device falls under product code NQB (Conformer, Ophthalmic, Biological Tissue), a Class II device regulated under 21 CFR 886.3130.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2003
- Date Received
- July 8, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Conformer, Ophthalmic, Biological Tissue
- Device Class
- Class II
- Regulation Number
- 886.3130
- Review Panel
- OP
- Submission Type
The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures.