Altus Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Altus Medical, Inc.” (first 2000, latest 2004), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 100 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 | 5 | 5 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
Review panels
Most recent Altus Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033768 | ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE | ILY | 2004-02-17 | 76 |
| K023954 | ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES | GEX | 2003-03-18 | 111 |
| K022226 | ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS | GEX | 2002-10-08 | 90 |
| K014040 | FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS | GEX | 2002-06-03 | 178 |
| K003202 | FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II | GEX | 2001-01-10 | 90 |
| K991798 | ACME MEDICAL AESTHETIC ND:YAG LASER | GEX | 2000-03-06 | 285 |
Recalls
openFDA lists no recalls under a recalling firm named Altus Medical, 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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Altus Medical, Inc. (4)
- Altus Medical (2)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Altus Partners, LLC (17 510(k)s)
- Altus Partners (1 510(k)s)
- Altus Spine (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Altus Medical, Inc.?
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Altus Medical, Inc.” (first 2000, latest 2004), across 2 product codes in 2 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 Altus Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Altus Medical, Inc. is 100 days.
Which FDA product codes appear under Altus Medical, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 5); ILY (Lamp, Infrared, Therapeutic Heating, 1).
Next steps
- See all 6 Altus Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Altus Medical, 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.