Amo Manufacturing USA, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Amo Manufacturing USA, LLC” (first 2015, latest 2023), plus 3 PMA decisions, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 91 days. Since 2017 the median was 83 days, against 90 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2015 | 1 | 181 |
| 2016 | 0 | — |
| 2017 | 1 | 53 |
| 2018 | 1 | 99 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 29 |
| 2022 | 1 | 83 |
| 2023 | 1 | 111 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Amo Manufacturing USA, LLC took a median 83 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OOE | Ophthalmic Femtosecond Laser | 5 | 5 |
| LZS | Excimer Laser System | 3 | 0 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
Review panels
Most recent Amo Manufacturing USA, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223838 | Catalys Precision Laser System | OOE | 2023-04-12 | 111 |
| K220516 | CATALYS Precision Laser system | OOE | 2022-05-17 | 83 |
| K210701 | CATALYS Precision Laser System | OOE | 2021-04-07 | 29 |
| K182083 | Catalys Precision Laser System | OOE | 2018-11-09 | 99 |
| K172002 | Catalys Precision Laser System | OOE | 2017-08-25 | 53 |
| K141852 | IFS ADVANCED FEMTOSECOND LASER SYSTEM | GEX | 2015-01-06 | 181 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P990010 | PMA | VISX EXCIMER LASER SYSTEM MODEL C STAR | 1999-11-19 |
| P930016 | PMA | VISX EXCIMER LASER SYSTEM MODELS B AND C | 1996-03-27 |
| P910062 | PMA | VISX MODELB/MODEL C EXCIMER LASER SYSTEM | 1995-09-29 |
Recalls
17 product recalls in 4 recall events; 2 initiated in the last five years. Most recent: 2021-10-21.
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 Amo Manufacturing USA, LLC?
FDA lists 6 510(k) clearances under the applicant name “Amo Manufacturing USA, LLC” (first 2015, latest 2023), plus 3 PMA decisions, across 3 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 Amo Manufacturing USA, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amo Manufacturing USA, LLC is 91 days. Since 2017: 83 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Amo Manufacturing USA, LLC?
The most frequent FDA product codes under this applicant name are OOE (Ophthalmic Femtosecond Laser, 5); LZS (Excimer Laser System, 3); GEX (Powered Laser Surgical Instrument, 1).
Next steps
- See all 6 Amo Manufacturing USA, LLC clearances with predicates and recalls
- Run predicate analysis for product code OOE, Amo Manufacturing USA, LLC'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.