Fluid Isolation Device
FDA 510(k) K091915 · Lenstec, Inc.
510(k) numberK091915
Submission
- Device name
- Fluid Isolation Device
- Applicant
- Lenstec, Inc.
St. Petersburg, FL, US - Received
- June 30, 2009
- Decision date
- October 27, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Fluid Isolation Device cleared by the FDA?
Fluid Isolation Device (K091915) received a 510(k) decision of Substantially Equivalent on October 27, 2009, 119 days after the submission was received.
What is the product code of K091915?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.