Wavelight Laser Technologie AG
North Reading, MA, US
Wavelight Laser Technologie AG appears in FDA device records in North Reading, MA. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Wavelight Laser Technologie AG between 2004 and 2006. The busiest year on record is 2005, with 4. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 3 |
| 2005 | 4 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K053604 | WAVELIGHT IDAS | GEX | Substantially Equivalent | |
| K052806 | BURANE | GEX | Substantially Equivalent | |
| K051399 | WAVELIGHT AURIGA | GEX | Substantially Equivalent | |
| K050317 | BURANE XL | GEX | Substantially Equivalent | |
| K050218 | WAVELIGHT SINON | GEX | Substantially Equivalent | |
| K042474 | ARION | GEX | Substantially Equivalent | |
| K040433 | SINON | GEX | Substantially Equivalent | |
| K040384 | MYDON C | GEX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain