Laser Engineering, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 18
- Inspections
- 5
- Compliance Actions
- 2
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K211605 | Dual Switch | September 22, 2022 |
| K141908 | DUAL SWITCH | October 22, 2014 |
| K924457 | MICROMANIPULATOR | May 7, 1993 |
| K912247 | UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY | November 13, 1991 |
| K912347 | BIPURE 1000 | September 23, 1991 |
| K910062 | 02-10,001 | August 16, 1991 |
| K911852 | COMPULSE CO2 SURGICAL LASER SYS. | June 7, 1991 |
| K905676 | MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH | April 22, 1991 |
| K875314 | GL-35 COLPOSCOPIC LASER SYSTEM | August 5, 1988 |
| K881588 | MODEL MD-25 LASER FOR SURGICAL USE | June 3, 1988 |
| K881584 | MODEL MD-45 CO2 LASER FOR NEUROSURGERY USE | June 3, 1988 |
| K881580 | MODEL MD-25 CO2 LASER FOR DERMA./PLASTIC SURGERY | June 3, 1988 |
| K881583 | MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROAT | June 3, 1988 |
| K881585 | MODEL MD-25 CO2 LASER FOR NEUROSURGERY USE | June 3, 1988 |
| K881581 | MODEL MD-45 CO2 LASER FOR OB-GYN & UROLOGICAL USE | June 3, 1988 |
| K881587 | MODEL MD-25 CO2 LASER FOR PODIATRY APPLICATIONS | June 3, 1988 |
| K881586 | MODEL MD-45 CO2 LASER FOR ENT APPLICATIONS | June 3, 1988 |
| K881582 | MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USE | June 3, 1988 |