Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hgm Medical Laser Systems, Inc. · Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
202 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921300 | MODEL PC ARGON ION LASER | Hgm Medical Laser Systems, Inc. | 1992-10-06 | 202 | 0 |
| K914484 | LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE | Hgm Medical Laser Systems, Inc. | 1992-01-06 | 90 | 0 |
| K913569 | COMPAC A, ELITE A, ELITE A PLUS, SURGICA A | Hgm Medical Laser Systems, Inc. | 1991-10-17 | 69 | 1 |
| K912628 | AIR ARGON ION LASERS VARIOUS MODELS | Hgm Medical Laser Systems, Inc. | 1991-09-13 | 88 | 0 |
| K910272 | HGM COMBINATION ND:YAG & SOLID STATE GREEN | Hgm Medical Laser Systems, Inc. | 1991-08-09 | 198 | 0 |
| K912438 | MODELS 5,8,20,20S ARGON ION LASERS | Hgm Medical Laser Systems, Inc. | 1991-07-17 | 44 | 0 |
| K910602 | HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY | Hgm Medical Laser Systems, Inc. | 1991-06-24 | 131 | 0 |
| K911104 | PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 | Hgm Medical Laser Systems, Inc. | 1991-06-11 | 90 | 0 |
| K910898 | SURGICA(TM) H | Hgm Medical Laser Systems, Inc. | 1991-05-31 | 88 | 0 |
| K904699 | COMPAC(TM) DIODE LASERS | Hgm Medical Laser Systems, Inc. | 1991-04-25 | 191 | 0 |
| K904700 | ENDOCOAGULATOR KRS568(TM) LASER | Hgm Medical Laser Systems, Inc. | 1991-02-19 | 126 | 0 |
| K904342 | SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A | Hgm Medical Laser Systems, Inc. | 1990-12-19 | 89 | 0 |
| K902258 | 5 MM IRRIGATION/ASPIRATION FIBER PROBE | Hgm Medical Laser Systems, Inc. | 1990-09-19 | 121 | 0 |
| K896314 | ENDOSCOPIC USES OF THE ARGON LASER IN GENERAL SURG | Hgm Medical Laser Systems, Inc. | 1990-05-10 | 190 | 0 |
| K901021 | F300 SERIES CONTACT FIBER HANDPIECES | Hgm Medical Laser Systems, Inc. | 1990-04-13 | 39 | 0 |
| K881507 | ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES | Hgm Medical Laser Systems, Inc. | 1989-04-27 | 381 | 0 |
| K890787 | O-020 LASER INDIRECT OPHTHALMOSCOPE | Hgm Medical Laser Systems, Inc. | 1989-03-24 | 37 | 0 |
| K881940 | MODEL 20 KY KRYPTON YELLOW LASER | Hgm Medical Laser Systems, Inc. | 1988-07-20 | 72 | 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