Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LLO — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
46 daysmedian FDA review time
184 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884815 | SLT CLMD CONTACT LASER | Surgical Laser Technologies, Inc. | 1988-12-22 | 35 | 0 |
| K881499 | SURGILASE YAG 100 FOR GYNECOLOGY USE | Surgilase, Inc. | 1988-04-29 | 38 | 0 |
| K880592 | LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE | Laser Peripherals, LLC | 1988-04-25 | 74 | 0 |
| K880170 | MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS | Cooper Lasersonics, Inc. | 1988-03-24 | 69 | 0 |
| K874254 | ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS | Minnesota Laser Corp. | 1988-03-04 | 136 | 0 |
| K875104 | SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE | Laserguide | 1988-02-02 | 46 | 0 |
| K871876 | MODEL 5050 SURGILASER FOR PULMONARY USE | Lasermatic, Inc. | 1988-01-22 | 253 | 0 |
| K872351 | FIBERLASE II ND:YAG LASER FOR PULMONARY USE | Laser Media | 1987-12-11 | 177 | 0 |
| K870505 | OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL | Trimedyne, Inc. | 1987-08-07 | 184 | 0 |
| K871511 | SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS | Medical Energy, Inc. | 1987-07-21 | 92 | 0 |
| K862698 | 6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION | Cooper Lasersonics, Inc. | 1986-08-05 | 21 | 0 |
| K861921 | LASER BRONCHOSCOPE SYSTEM | Pilling Co. | 1986-06-02 | 14 | 0 |
| K861583 | CO2 LASER BRONCHOSCOPE SYSTEM | Richard Wolf Medical Instruments Corp. | 1986-05-21 | 22 | 0 |
| K861045 | MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT | Sharplan Industries, Inc. | 1986-04-23 | 36 | 0 |
| K855095 | S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA | Surgical Laser Technologies, Inc. | 1986-02-18 | 57 | 0 |
| K852761 | CILAS MODEL YM101 | Inframed, Inc. | 1985-11-14 | 139 | 0 |
| K852507 | ND: YAGLASER FOR PALLIATIVE TREAT OF OBSTRUCTION | Endo Lase, Inc. | 1985-07-05 | 23 | 0 |
| K850432 | LASER BENIGN & MALIGNANT PULMONARY OBSTRUCTIONS- | Cooper Lasersonics, Inc. | 1985-02-15 | 11 | 0 |
| K844869 | FIBERLASE 100 MEDICAL LASER SYSTEM | Laser Media | 1985-01-14 | 31 | 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