Hgm Medical Laser Systems, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Hgm Medical Laser Systems, Inc.” (first 1988, latest 1992), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 12 | 12 |
| FEX | Instrument, Catheter, Punch | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| HGF | Source, Abortion Unit, Vacuum | 1 | 1 |
| HHR | Laser, Surgical, Gynecologic | 1 | 1 |
| HLI | Ophthalmoscope, Ac-Powered | 1 | 1 |
| HQF | Laser, Ophthalmic | 1 | 1 |
Review panels
- General and Plastic Surgery (12)
- Obstetrics and Gynecology (3)
- Ophthalmic (2)
- Gastroenterology and Urology (1)
Most recent Hgm Medical Laser Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921300 | MODEL PC ARGON ION LASER | GEX | 1992-10-06 | 202 |
| K914484 | LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE | HLI | 1992-01-06 | 90 |
| K913569 | COMPAC A, ELITE A, ELITE A PLUS, SURGICA A | GEX | 1991-10-17 | 69 |
| K912628 | AIR ARGON ION LASERS VARIOUS MODELS | GEX | 1991-09-13 | 88 |
| K910272 | HGM COMBINATION ND:YAG & SOLID STATE GREEN | GEX | 1991-08-09 | 198 |
| K912438 | MODELS 5,8,20,20S ARGON ION LASERS | GEX | 1991-07-17 | 44 |
| K910602 | HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY | GEX | 1991-06-24 | 131 |
| K911104 | PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 | FEX | 1991-06-11 | 90 |
| K910898 | SURGICA(TM) H | GEX | 1991-05-31 | 88 |
| K904699 | COMPAC(TM) DIODE LASERS | HQF | 1991-04-25 | 191 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hgm Medical Laser Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hgm Medical Laser Systems, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Hgm Medical Laser Systems, Inc.” (first 1988, latest 1992), across 7 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hgm Medical Laser Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hgm Medical Laser Systems, Inc. is 90 days.
Which FDA product codes appear under Hgm Medical Laser Systems, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 12); FEX (Instrument, Catheter, Punch, 1); HET (Laparoscope, Gynecologic (And Accessories), 1).
Next steps
- See all 18 Hgm Medical Laser Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Hgm Medical Laser Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.