Katalyst Cyclophotocoagulation Probe
FDA 510(k) clearance K163632 · decided 2017-06-15
Clearance details
- K-number
- K163632
- Device name
- Katalyst Cyclophotocoagulation Probe
- Applicant
- Katalyst Surgical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-12-22
- Decision date
- 2017-06-15
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- LQJ
- Device class
- 2
- Regulation number
- 886.4390
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chesterfield, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR (K931356) | Sorenson Laboratories, Inc. | 1993-09-07 |
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| PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 (K912112) | Tomey Corporation USA | 1991-06-17 |
| SHIELDS T.C. LASER LENS (K893731) | Ocular Instruments, Inc. | 1989-08-17 |
| MQL 20 ND:YAG OPHTHALMIC LASER (K884694) | California Laboratories, Inc. | 1988-11-30 |
| INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM (K883719) | Biophysic Medical, Inc. | 1988-10-18 |
| IRIS ND:YAG OPTHALMIC LASER (K883270) | California Laboratories, Inc. | 1988-10-13 |
| BOLDREY PERIPHERAL RETINAL LENS (K882574) | Ocular Instruments, Inc. | 1988-07-29 |
| TROKEL SINGLE MIRROR YAG LASER LENS (K872802) | Ocular Instruments, Inc. | 1987-09-04 |
| LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1 (K871245) | Chiron Vision Corp. | 1987-05-07 |
| SCHIRMER NYLON SUTURE LASER LENS (K871099) | Ocular Instruments, Inc. | 1987-04-27 |
| PETRUS SINGLE MIRROR LASER LENS (K862869) | Ocular Instruments, Inc. | 1986-08-21 |
Recalls involving this device
No recalls on record reference this clearance.