510(k) K040204
- Device
- ZYOPTIX XP MICROKERATOME
- Applicant
- BAUSCH & LOMB, INC.
- 510(k) number
- K040204
- Product code
- HNO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-03-22
- Date received
- 2004-01-29
- Regulation
- 886.4370
- Classification name
- Keratome, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBRA L.B. KETCHUM
- Address
- 1400 N. Goodman St. Rochester NY US 14609 14609
FDA Registration Numbers#
- 3003288808
- 3000264417
- 1644019
- 8043792
- 2029275
- 3010208880
- 3038356864
- 3007606649
- 1920664
- 9615659
- 2246552
- 9615030
- 1226074
- 3012236936
- 3010487482
- 3006695864
- 2028159
- 3004858034
- 3009298127
- 3005941719
- 1649518
- 3016214537
- 9710340
- 1043653
- 1928237
- 3005263901
- 2085081
- 3005012805
- 3010383847
- 1650907
- 3010291427
Source Documents#
Other 510(k) Records For Product Code HNO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K173371 | VisuMax Femtosecond Laser | Carl Zeiss Meditec, Inc. | 2018-04-13 |
| K172994 | EPI K Console | Moria SA | 2017-10-26 |
| K072102 | EPIVISION SL SYSTEM | Gebauer Medizintechnik GmbH | 2009-01-16 |
| K082043 | CARRIAZO-PENDULAR MICROKERATOME | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2008-08-01 |
| K062465 | ZYOPTIX XP EPI SEPARATOR SYSTEM | Bausch & Lomb, Inc. | 2006-09-06 |
| K052891 | HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM | Hawken Industries | 2006-03-23 |
| K051486 | NORWOOD ABBEY CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | 2005-07-06 |
| K043183 | EPI-K | Moria SA | 2005-03-25 |
| K043150 | AMADEUS II EPIKERATOME | Sis Ltd., Surgical Instrument Systems | 2005-01-31 |
| K042083 | MODIFICATION TO VISITOME 20-10 MICROKERATOME | Biovision AG | 2004-11-16 |
| K042810 | CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | 2004-10-28 |
| K041110 | MB 105 MILLENNIUM BLADES | Millennium Biomedical, Inc. | 2004-10-13 |
| K041206 | EPITOME SYSTEM | Gebauer Medizintechnik GmbH | 2004-09-15 |
| K032910 | CARRIAZO PENDULAR | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2004-08-30 |
| K032836 | M3 MICROKERATOME | Moria SA | 2004-06-18 |
Legacy Summary#
summary
FDA Review#
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