510(k) K242184
K242184 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);". The FDA issued a decision of Substantially Equivalent on December 4, 2024. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. Alcon Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 2024
- Date Received
- July 25, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoilluminator
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- OP
- Submission Type