← FDA Medical Device Classifications
Extended Depth Of Focus Intraocular Lens
POE · Class III — High Risk (PMA approval required, life-sustaining) · Ophthalmic · 21 CFR 886.3600
Classification
- FDA Product Code
POE- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 886.3600
- Review panel
- OP
- Medical specialty
- Ophthalmic
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
Intended to be implanted to replace the natural lens of an eye.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 16
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown