Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laser Industries , Ltd. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
268 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933362 | SHARPLAN CO2 SURGICAL LASER | Laser Industries , Ltd. | 1994-04-07 | 272 | 0 |
| K894765 | SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 | Laser Industries , Ltd. | 1989-09-28 | 64 | 0 |
| K850633 | SHARPLAN MODEL 1060 CO/2 SURGICAL LASER | Laser Industries , Ltd. | 1985-08-07 | 169 | 0 |
| K850628 | SHARPLAN 1040 CO/2 SURGICAL LASER | Laser Industries , Ltd. | 1985-08-07 | 169 | 0 |
| K842997 | LASER RECTOSCOPE SET 784 | Laser Industries , Ltd. | 1984-08-27 | 28 | 0 |
| K832550 | SHARPLAN #734 LASER SURGICAL UNIT | Laser Industries , Ltd. | 1984-04-25 | 268 | 0 |
| K832551 | SHARPLAN #745 LASER SURG. UNIT | Laser Industries , Ltd. | 1984-04-23 | 266 | 0 |
| K832316 | OPHTHALMIC ARGON LASER #700A | Laser Industries , Ltd. | 1984-01-30 | 199 | 0 |
| K837573 | SHARPLAN LASER POSITIONING SYSTEM | Laser Industries , Ltd. | 1983-06-28 | 32 | 0 |
| K837342 | SHARPLAN 721 CO2 SURGICAL LASER | Laser Industries , Ltd. | 1983-05-18 | 71 | 0 |
| K837081 | MICROSCAN 771 MANIPULATOR | Laser Industries , Ltd. | 1983-03-09 | 43 | 0 |
| K828056 | MODEL 716 MICROMANIPULATOR | Laser Industries , Ltd. | 1983-01-06 | 31 | 0 |
| K828194 | LASER LAPAROSCOPE | Laser Industries , Ltd. | 1982-10-05 | 27 | 0 |
| K827607 | MODEL 712 MICROMANIPULATOR | Laser Industries , Ltd. | 1982-07-22 | 48 | 0 |
| K820101 | SHARPLAN 720 CO2 SURGICAL LASER | Laser Industries , Ltd. | 1982-02-24 | 40 | 0 |
| K801624 | SHARPLAN 723 CO2 LASER SURGICAL SYSTEM | Laser Industries , Ltd. | 1980-08-20 | 36 | 0 |
| K792418 | SHARPLAN 743, CO2 LASER SURGICAL SYSTEM | Laser Industries , Ltd. | 1980-02-05 | 70 | 0 |
| K790526 | LIO-714 OPACITYMETER | Laser Industries , Ltd. | 1979-11-16 | 246 | 0 |
| K782030 | LASER SYSTEM, SHARPLAN 791/HE, CO2 | Laser Industries , Ltd. | 1979-01-22 | 48 | 0 |
| K780585 | SURGICAL LASER | Laser Industries , Ltd. | 1978-07-19 | 99 | 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