Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Endo Lase, Inc. — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
171 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853900 | ENDO-LASE CD40 FOR NEUROSURGERY | Endo Lase, Inc. | 1986-06-18 | 271 | 0 |
| K853878 | ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY | Endo Lase, Inc. | 1986-05-02 | 227 | 0 |
| K855093 | MEDILAS 2 ND:YAG LASER SURGERY SYSTEM | Endo Lase, Inc. | 1986-02-21 | 63 | 0 |
| K853876 | ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY | Endo Lase, Inc. | 1986-02-21 | 157 | 0 |
| K853903 | ENDO-LASE CD40 CO2 FOR GYNECOLOGY | Endo Lase, Inc. | 1986-02-21 | 154 | 0 |
| K853877 | ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY | Endo Lase, Inc. | 1986-02-19 | 155 | 0 |
| K853901 | ENDO-LASE CD 40 FOR DERMATOLOGY | Endo Lase, Inc. | 1986-02-19 | 152 | 0 |
| K853580 | MEDILAS 2 | Endo Lase, Inc. | 1986-02-13 | 171 | 0 |
| K860152 | MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY | Endo Lase, Inc. | 1986-02-05 | 21 | 0 |
| K853875 | ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY | Endo Lase, Inc. | 1986-01-09 | 114 | 0 |
| K853902 | ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY | Endo Lase, Inc. | 1986-01-09 | 111 | 0 |
| K853904 | ENDO-LASE CD40 FOR UROLOGY | Endo Lase, Inc. | 1985-10-25 | 35 | 0 |
| K853874 | ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA- | Endo Lase, Inc. | 1985-10-25 | 38 | 0 |
| K852507 | ND: YAGLASER FOR PALLIATIVE TREAT OF OBSTRUCTION | Endo Lase, Inc. | 1985-07-05 | 23 | 0 |
| K851527 | UTILIZATION OF ND:YAG LASER FOR TREATMENT RECTAL P | Endo Lase, Inc. | 1985-05-17 | 31 | 0 |
| K844460 | ND. YAG LASER RECTAL PATHOLOGY | Endo Lase, Inc. | 1985-01-16 | 62 | 0 |
| K844459 | ND:YAG LASER UROLOGICAL SURGERY | Endo Lase, Inc. | 1985-01-16 | 62 | 0 |
| K844458 | ND:YAG LASER PULMONARY OBSTRUCTION | Endo Lase, Inc. | 1985-01-03 | 49 | 0 |
| K842810 | INFRARED COAGULATOR | Endo Lase, Inc. | 1984-10-18 | 92 | 0 |
| K843293 | ND-YAG LASER FOR UROLOGICAL SURGERY | Endo Lase, Inc. | 1984-10-02 | 42 | 0 |
| K843374 | ND-YAG LASER FOR PALLIATION OF GI MALIGN | Endo Lase, Inc. | 1984-10-02 | 35 | 0 |
| K843228 | ND. YAG LASER FOR ENDOBRONCHIAL OBSTRUC | Endo Lase, Inc. | 1984-09-04 | 19 | 0 |
| K834487 | FLEXIBLE LIQUID LIGHT GUIDE | Endo Lase, Inc. | 1984-02-21 | 70 | 0 |
| K833557 | MEDILAS LASER | Endo Lase, Inc. | 1984-02-07 | 123 | 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