Micropulse Phacoemulsification System
FDA 510(k) K051186 · Trillium Medical, Inc.
510(k) numberK051186
Submission
- Device name
- Micropulse Phacoemulsification System
- Applicant
- Trillium Medical, Inc.
Poulsbo, WA, US - Received
- May 9, 2005
- Decision date
- August 18, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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Questions and answers
When was Micropulse Phacoemulsification System cleared by the FDA?
Micropulse Phacoemulsification System (K051186) received a 510(k) decision of Substantially Equivalent on August 18, 2005, 101 days after the submission was received.
What is the product code of K051186?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.