Hi-Line Medical Phacoemulsifier Tip
FDA 510(k) K952468 · Hi-Line Medical
510(k) numberK952468
Submission
- Device name
- Hi-Line Medical Phacoemulsifier Tip
- Applicant
- Hi-Line Medical
Laguna Hills, CA, US - Received
- May 26, 1995
- Decision date
- August 24, 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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| 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 Hi-Line Medical Phacoemulsifier Tip cleared by the FDA?
Hi-Line Medical Phacoemulsifier Tip (K952468) received a 510(k) decision of Substantially Equivalent on August 24, 1995, 90 days after the submission was received.
What is the product code of K952468?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.