510(k) K081565
K081565 is an FDA 510(k) premarket notification submitted by Ellex Medical Pty, Ltd. for the device "INTEGRE PRO, MODEL L2RY". The FDA issued a decision of Substantially Equivalent on July 2, 2008. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Ellex Medical Pty, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2008
- Date Received
- June 4, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.4390
- Review Panel
- OP
- Submission Type