← FDA Medical Device Classifications
Plug, Scleral
LXP · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.4155
Classification
- FDA Product Code
LXP- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 886.4155
- Review panel
- OP
- Medical specialty
- Ophthalmic
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Intended to provide temporary closure of a scleral incision during an ophthalmic procedure.
Market data
- Cleared 510(k) submissions
- 10
- Registered establishments
- 2
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown