Panels › Ophthalmic › Product code HNO · Class 1
Keratome, Ac-Powered
Regulation 886.4370
0510(k)s in 12 months (83 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in HNO
| Company | 510(k)s | Recalls |
|---|---|---|
| Bausch & Lomb, Inc. | 4 | 4 |
| Med-Logics, Inc. | 7 | 1 |
| Millennium Biomedical, Inc. | 5 | 0 |
| Oasis Medical, Inc. | 5 | 0 |
| Micro Specialties, Inc. | 4 | 0 |
| Moria SA | 4 | 0 |
| Surgin Surgical Instrumentation, Inc. | 4 | 0 |
| AMO Manufacturing USA, LLC | 0 | 3 |
| Howard Instruments, Inc. | 3 | 0 |
| Lasersight Technologies, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2015 | Med-logics Inc ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10.
ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar ke Terminated |
HNO | K033293 |
| Nov 4, 2011 | AMO Manufacturing USA, LLC Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number: J20007D/J/K;
Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA
Product Usage: Intended Terminated |
HNO | K031960 |
| Nov 4, 2011 | AMO Manufacturing USA, LLC Abbott brand IntraLase Femtosecond Laser System, Model 3; Catalog Numbers: 20004D/J/K, R20004J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA
Product Usage: Terminated |
HNO | K031960 |
| Nov 4, 2011 | AMO Manufacturing USA, LLC Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA
Pr Terminated |
HNO | K031960 |
| May 25, 2011 | Wavelight AG WaveLight FS200 Femtosecond Laser System
Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2.
The WaveLight FS 200 Laser System is an ophthalmic surgi Terminated |
HNO | K101006 |
| Oct 22, 2008 | Bausch & Lomb Inc Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components, one of which is the maxon motor. The label shows the product is manufactured by Bausch & Lomb Incorporated, Roches Terminated |
HNO | K040204 |
| Oct 22, 2008 | Bausch & Lomb Inc Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY. Terminated |
HNO | K040204 |
| Aug 2, 2007 | Bausch & Lomb Inc Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reuseable. Ophthalmic surgical accessory. NOTE: The label only names the product as Zyoptix XP Microkeratome. Terminated |
HNO | K040204 |
| Aug 2, 2007 | Bausch & Lomb Inc Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507-0068, RX, for single use only. Ophthalmic surgical accessory. The product is labeled as Manufactu Terminated |
HNO | K040204 K062465 |
| Mar 6, 2003 | Alcon Laboratories, Inc SKBM Microkeratome cutting tool Terminated |
HNO | K980675 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.