Benjamin Envoy Phaco Handpiece
FDA 510(k) K022833 · Benjamin Biomedical, Inc.
510(k) numberK022833
Submission
- Device name
- Benjamin Envoy Phaco Handpiece
- Applicant
- Benjamin Biomedical, Inc.
Appollo Beach, FL, US - Received
- August 26, 2002
- Decision date
- September 9, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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| K232084 | Stellaris Elite vision enhancement systemHQC · Traditional | Bausch and Lomb | 02/26/2024SE |
| K233902 | Centurion Vision System (Active Sentry) (8065753057)HQC · Special | Alcon Laboratories, Inc. | 01/10/2024SE |
Questions and answers
When was Benjamin Envoy Phaco Handpiece cleared by the FDA?
Benjamin Envoy Phaco Handpiece (K022833) received a 510(k) decision of Substantially Equivalent on September 9, 2002, 14 days after the submission was received.
What is the product code of K022833?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.