U.S. Iol Phaco Handpiece
FDA 510(k) K954239 · U.S. Iol, Inc.
510(k) numberK954239
Submission
- Device name
- U.S. Iol Phaco Handpiece
- Applicant
- U.S. Iol, Inc.
Temple City, CA, US - Received
- September 11, 1995
- Decision date
- December 8, 1995
- 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 U.S. Iol Phaco Handpiece cleared by the FDA?
U.S. Iol Phaco Handpiece (K954239) received a 510(k) decision of Substantially Equivalent on December 8, 1995, 88 days after the submission was received.
What is the product code of K954239?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.