Horizon Phacoemulsification System, Model HZN-2030
FDA 510(k) K020527 · American Optisurgical, Inc.
510(k) numberK020527
Submission
- Device name
- Horizon Phacoemulsification System, Model HZN-2030
- Applicant
- American Optisurgical, Inc.
Lake Forest, CA, US - Received
- February 19, 2002
- Decision date
- July 9, 2002
- 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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More from Alcon Laboratories, Inc.
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|---|---|---|
| K101561 | TX1 Tissue Removal SystemLFL · Traditional | 08/27/2010SE |
| K080803 | Visual Phacoemulsification System, Model 551HQC · Traditional | 09/22/2008SE |
| K953539 | DM001 Disposable PackHQC · Traditional | 12/26/1995SE |
| K953538 | RM001 ReusableHQC · Traditional | 12/26/1995SE |
| K952331 | Aoi LC-40 PhacoemulsifierHQC · Traditional | 08/16/1995SE |
Questions and answers
When was Horizon Phacoemulsification System, Model HZN-2030 cleared by the FDA?
Horizon Phacoemulsification System, Model HZN-2030 (K020527) received a 510(k) decision of Substantially Equivalent on July 9, 2002, 140 days after the submission was received.
What is the product code of K020527?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.