ULTRASHAPER KERATOME
FDA 510(k) clearance K990227 · decided 2000-01-31
Clearance details
- K-number
- K990227
- Device name
- ULTRASHAPER KERATOME
- Applicant
- Lasersight Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-25
- Decision date
- 2000-01-31
- Days to decision
- 371 days
- Clearance type
- Traditional
- Product code
- HNO
- Device class
- 1
- Regulation number
- 886.4370
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Winter Park, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Lasersight Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VisuMax Femtosecond Laser (K173371) | Carl Zeiss Meditec, Inc. | 2018-04-13 |
| EPI K Console (K172994) | Moria SA | 2017-10-26 |
| EPIVISION SL SYSTEM (K072102) | Gebauer Medizintechnik GmbH | 2009-01-16 |
| CARRIAZO-PENDULAR MICROKERATOME (K082043) | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2008-08-01 |
| ZYOPTIX XP EPI SEPARATOR SYSTEM (K062465) | Bausch & Lomb, Inc. | 2006-09-06 |
| HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM (K052891) | Hawken Industries | 2006-03-23 |
| NORWOOD ABBEY CENTURION SES EPIKERATOME (K051486) | Norwood Abbey , Ltd. | 2005-07-06 |
| EPI-K (K043183) | Moria SA | 2005-03-25 |
| AMADEUS II EPIKERATOME (K043150) | Sis Ltd., Surgical Instrument Systems | 2005-01-31 |
| MODIFICATION TO VISITOME 20-10 MICROKERATOME (K042083) | Biovision AG | 2004-11-16 |
| CENTURION SES EPIKERATOME (K042810) | Norwood Abbey , Ltd. | 2004-10-28 |
| MB 105 MILLENNIUM BLADES (K041110) | Millennium Biomedical, Inc. | 2004-10-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LSX EXCIMER LASER SYSTEM (P980008/S012) | Lasersight Technologies, Inc. | 2002-12-16 |
| LASERSCAN LSX EXCIMER LASER SYSTEM (P980008/S009) | Lasersight Technologies, Inc. | 2001-11-09 |
| LASERSCAN LSX EXCIMER LASER SYSTEM (P980008/S008) | Lasersight Technologies, Inc. | 2001-10-25 |
| LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK) (P980008/S005) | Lasersight Technologies, Inc. | 2001-09-28 |
| LASERSCAN LSX EXCIMER LASER (P980008/S002) | Lasersight Technologies, Inc. | 2000-10-27 |
| LASER SCAN LSX EXCIMER LASER (P980008/S003) | Lasersight Technologies, Inc. | 2000-08-15 |
| LASERSCAN LSX EXCIMER LASER SYSTEM (P980008) | Lasersight Technologies, Inc. | 1999-11-12 |
| KREMER LASER SYSTEM (P970005) | Lasersight Technologies, Inc. | 1998-07-30 |