Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
L.A.S.E.R., Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
320 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983965 | CO2 LASER COUPLER | L.A.S.E.R., Inc. | 1998-12-22 | 46 | 0 |
| K950021 | REUSABLE TROCAR WITH SAFETY SLEEVE | L.A.S.E.R., Inc. | 1995-03-31 | 86 | 0 |
| K940454 | GRASPING FORCEPS, PUNCHES, SCISSORS | L.A.S.E.R., Inc. | 1994-03-25 | 52 | 0 |
| K931561 | TROCAR SLEEVE | L.A.S.E.R., Inc. | 1994-02-07 | 314 | 0 |
| K933421 | ENDOSCOPIC INSTRUMENTS AND ACCESSDORIES | L.A.S.E.R., Inc. | 1993-11-02 | 112 | 0 |
| K924844 | BULK TISSUE REMOVAL SYSTEM | L.A.S.E.R., Inc. | 1993-10-08 | 375 | 0 |
| K932045 | DISPOSABLE INSUFFLATION TUBING | L.A.S.E.R., Inc. | 1993-09-23 | 149 | 0 |
| K931092 | ENDOSCOPIC RETRACTOR | L.A.S.E.R., Inc. | 1993-04-30 | 58 | 0 |
| K914197 | ALLOY SCALPEL HANDPIECES | L.A.S.E.R., Inc. | 1992-04-10 | 204 | 0 |
| K904638 | TROCAR DISPOSABLE | L.A.S.E.R., Inc. | 1991-02-21 | 133 | 0 |
| K892912 | MODEL JM-1 CO2 LASER | L.A.S.E.R., Inc. | 1990-03-06 | 320 | 0 |
| K852901 | DOUBLE PUNCTURE INSTRUMENTS | L.A.S.E.R., Inc. | 1985-10-16 | 99 | 0 |
| K852415 | TITANIUM PROBES | L.A.S.E.R., Inc. | 1985-08-02 | 56 | 0 |
| K844829 | ABDOMINAL PRESSURE CONTROL VALVE | L.A.S.E.R., Inc. | 1985-05-01 | 140 | 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