Phaco 3000 Linear
FDA 510(k) K915456 · Innovative Medical Systems, Inc.
510(k) numberK915456
Submission
- Device name
- Phaco 3000 Linear
- Applicant
- Innovative Medical Systems, Inc.
Commack, NY, US - Received
- December 5, 1991
- Decision date
- February 12, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K915457 | Phaco 20/20 System IHQC · Traditional | 02/24/1992SE |
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Questions and answers
When was Phaco 3000 Linear cleared by the FDA?
Phaco 3000 Linear (K915456) received a 510(k) decision of Substantially Equivalent on February 12, 1992, 69 days after the submission was received.
What is the product code of K915456?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.