Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ceram Optec, Inc. — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
184 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002296 | CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G | Ceram Optec, Inc. | 2000-10-02 | 66 | 0 |
| K001975 | CERALAS D10 810NM LASER, MODEL CERALAS D10-60 | Ceram Optec, Inc. | 2000-08-04 | 36 | 0 |
| K993828 | CERALAS D10 810NM DIODE LASER | Ceram Optec, Inc. | 2000-02-01 | 81 | 0 |
| K993911 | CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50 | Ceram Optec, Inc. | 2000-02-01 | 77 | 0 |
| K993002 | CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 | Ceram Optec, Inc. | 1999-10-14 | 37 | 0 |
| K992773 | CERALAS D10 810NM DIODE LASER | Ceram Optec, Inc. | 1999-09-01 | 14 | 0 |
| K991891 | CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15 | Ceram Optec, Inc. | 1999-06-24 | 21 | 0 |
| K983950 | CERALAS DIODE LASER SYSTEM (MODEL H) | Ceram Optec, Inc. | 1999-02-03 | 90 | 0 |
| K983058 | CERALAS D LASER SYSTEM, MODEL # CERALAS D15 | Ceram Optec, Inc. | 1998-10-21 | 50 | 0 |
| K980389 | MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES | Ceram Optec, Inc. | 1998-07-29 | 177 | 0 |
| K981126 | CERALAS G FREQUENCY DOUBLED ND: YAG LASER SYSTEMS, CERALAS G | Ceram Optec, Inc. | 1998-06-25 | 90 | 0 |
| K980838 | REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM | Ceram Optec, Inc. | 1998-06-02 | 90 | 0 |
| K964751 | CERALAS DIODE LASER SYSTEM (CERALAS D2) | Ceram Optec, Inc. | 1997-02-21 | 87 | 0 |
| K964497 | CERALAS DIODE LASER SYSTEM (CERALAS D15) | Ceram Optec, Inc. | 1997-02-06 | 90 | 0 |
| K962948 | CERALAS G ND;YAG LASER SYSTEM (CERALAS G) | Ceram Optec, Inc. | 1996-10-25 | 88 | 0 |
| K953851 | CERALAS F ND:YAG LASER SYSTEM | Ceram Optec, Inc. | 1996-02-16 | 184 | 0 |
| K954834 | CERALAS G FREQUENCY DOUBLED ND;YAG LASER SYSTEM | Ceram Optec, Inc. | 1996-01-17 | 89 | 0 |
| K952772 | MEGABEAM ENDO-ENT PROBE | Ceram Optec, Inc. | 1995-07-17 | 31 | 0 |
| K951775 | CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50) | Ceram Optec, Inc. | 1995-07-17 | 91 | 0 |
| K952340 | MEGABEAM ASPIRATING ENDOCULAR PROBE | Ceram Optec, Inc. | 1995-06-12 | 24 | 0 |
| K943527 | MEGABEAM LATERAL FIRE | Ceram Optec, Inc. | 1994-12-05 | 137 | 0 |
| K943526 | MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYSTEM | Ceram Optec, Inc. | 1994-08-26 | 36 | 0 |
| K943444 | MEGABEAM LATERAL FIRE | Ceram Optec, Inc. | 1994-08-26 | 39 | 0 |
| K943445 | MEGABEAM FIBER OPTIC DELIVERY SYSTEM | Ceram Optec, Inc. | 1994-08-26 | 39 | 0 |
| K942182 | MEGABEAM DENTAL FIBER | Ceram Optec, Inc. | 1994-07-06 | 63 | 0 |
| K935747 | MEGABEAM ENDOCULAR PROBE | Ceram Optec, Inc. | 1994-04-01 | 121 | 0 |
| K924258 | MEGABEAM RADIAL EMIT SHAPE FIBER OPTIC DELIV SYST | Ceram Optec, Inc. | 1994-03-09 | 562 | 0 |
| K934008 | MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYST | Ceram Optec, Inc. | 1994-01-03 | 139 | 0 |
| K923543 | MIS | Ceram Optec, Inc. | 1993-03-29 | 256 | 0 |
| K923953 | MEGABEAM | Ceram Optec, Inc. | 1992-11-17 | 103 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda