Epsilon Ultrasonic Tip
FDA 510(k) K831836 · CooperVision, Inc.
510(k) numberK831836
Submission
- Device name
- Epsilon Ultrasonic Tip
- Applicant
- CooperVision, Inc.
Southampton, GB - Received
- June 7, 1983
- Decision date
- June 30, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Epsilon Ultrasonic Tip cleared by the FDA?
Epsilon Ultrasonic Tip (K831836) received a 510(k) decision of Substantially Equivalent on June 30, 1983, 23 days after the submission was received.
What is the product code of K831836?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.