Phaco Chop Needles
FDA 510(k) K041998 · Bausch & Lomb, Inc.
510(k) numberK041998
Submission
- Device name
- Phaco Chop Needles
- Applicant
- Bausch & Lomb, Inc.
St. Louis, MO, US - Received
- July 26, 2004
- Decision date
- August 16, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Phaco Chop Needles cleared by the FDA?
Phaco Chop Needles (K041998) received a 510(k) decision of Substantially Equivalent on August 16, 2004, 21 days after the submission was received.
What is the product code of K041998?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.