Laser Engineering Heart, Inc.: FDA clearances and approvals
Laser Engineering Heart, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNO | System, Laser, Transmyocardial Revascularization | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P950015 | PMA | THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION | 1998-08-20 |
Recalls
openFDA lists no recalls under a recalling firm named Laser Engineering Heart, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Laser Engineering Heart, Inc. have?
Laser Engineering Heart, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Laser Engineering Heart, Inc. make?
Its most frequent FDA product codes are MNO (System, Laser, Transmyocardial Revascularization, 1).
Has Laser Engineering Heart, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Laser Engineering Heart, Inc. Related entities may recall under other names.
Next steps
- See all 0 Laser Engineering Heart, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MNO, Laser Engineering Heart, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.