510(k) K961242
- Device
- AMO PHACOFLEX II INTERSECTION SYSTEM
- Applicant
- ALLERGAN, INC.
- 510(k) number
- K961242
- Product code
- KYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-06-17
- Date received
- 1996-04-01
- Regulation
- 886.4300
- Classification name
- Lens, Guide, Intraocular
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MAUREEN WEINER
- Address
- 2525 Dupont Dr. Irvine CA US 92612 92612
FDA Registration Numbers#
- 3017636737
- 8021817
- 2529846
- 3010148516
- 1644019
- 9681862
- 3010208880
- 3003951061
- 2648035
- 1220477
- 1119421
- 3023657851
- 1219313
- 3010047402
- 3009646326
- 2023826
- 3006946276
- 1054811
- 3012236936
- 3003365815
- 1313525
- 2028159
- 3014173684
- 2434839
- 9680271
- 1119279
- 2183946
- 3005067367
- 1047843
- 1211998
- 2523835
- 1319639
- 3003591781
- 1928237
- 1064005
- 3005012805
- 3007530141
- 1650907
Source Documents#
Other 510(k) Records For Product Code KYB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152357 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | 2015-10-30 |
| K081382 | DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 | Duckworth & Kent, Ltd. | 2008-10-23 |
| K072985 | DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 | Duckworth & Kent, Ltd. | 2008-06-20 |
| K070669 | IOL INJECTOR SET | Medicel AG | 2007-11-01 |
| K063155 | MONARCH III IOL DELIVERY SYSTEM | Alcon Manufacturing, Ltd. | 2007-03-27 |
| K063694 | AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 | Bausch & Lomb, Inc. | 2007-03-07 |
| K032412 | RE-USEABLE MICROSTAAR INJECTOR, MSI-S | Staar Surgical Co. | 2004-06-10 |
| K022723 | MASTEL 1 FOLDER IMPLANTATION SYSTEM | Mastel Precision, Inc. | 2002-12-26 |
| K001157 | MONARCH II IOL DELIVERY SYSTEM | Alcon Research, Ltd. | 2000-06-27 |
| K983129 | DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) | Staar Surgical Co. | 1998-12-04 |
| K981571 | MONARCH IOL DELIVERY SYSTEM | Alcon Laboratories | 1998-07-09 |
| K970033 | MONARCH IOL DELIVERY SYSTEM | Alcon Laboratories | 1997-04-23 |
| K965185 | ACRYPAK FOLDER | Alcon Laboratories | 1997-03-31 |
| K954600 | MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) | Staar Surgical Co. | 1995-12-21 |
| K951292 | PASSPORT FOLDABLE LENS PLACEMENT SYSTEM | Chiron Vision Corp. | 1995-06-02 |
Legacy Summary#
summary
FDA Review#
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