Laser Engineering, Inc.
Nashville, TN, US
LASER ENGINEERING, INC. appears in FDA device records in Nashville, TN. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Laser Engineering, Inc. between 1988 and 2022. The busiest year on record is 1988, with 10. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 10 |
| 1991 | 5 |
| 1993 | 1 |
| 2014 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K211605 | Dual Switch | GEX | Substantially Equivalent | |
| K141908 | DUAL SWITCH | GEX | Substantially Equivalent | |
| K924457 | MICROMANIPULATOR | GEX | Substantially Equivalent | |
| K912247 | UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY | GCJ | Substantially Equivalent | |
| K912347 | BIPURE 1000 | FYD | Substantially Equivalent | |
| K910062 | 02-10,001 | GEX | Substantially Equivalent | |
| K911852 | COMPULSE CO2 SURGICAL LASER SYS. | GEX | Substantially Equivalent | |
| K905676 | MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH | GEX | Substantially Equivalent | |
| K875314 | GL-35 COLPOSCOPIC LASER SYSTEM | HHR | Substantially Equivalent | |
| K881588 | MODEL MD-25 LASER FOR SURGICAL USE | GEX | Substantially Equivalent | |
| K881587 | MODEL MD-25 CO2 LASER FOR PODIATRY APPLICATIONS | GEX | Substantially Equivalent | |
| K881586 | MODEL MD-45 CO2 LASER FOR ENT APPLICATIONS | GEX | Substantially Equivalent | |
| K881585 | MODEL MD-25 CO2 LASER FOR NEUROSURGERY USE | GEX | Substantially Equivalent | |
| K881584 | MODEL MD-45 CO2 LASER FOR NEUROSURGERY USE | GEX | Substantially Equivalent | |
| K881583 | MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROAT | GEX | Substantially Equivalent | |
| K881582 | MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USE | GEX | Substantially Equivalent | |
| K881581 | MODEL MD-45 CO2 LASER FOR OB-GYN & UROLOGICAL USE | GEX | Substantially Equivalent | |
| K881580 | MODEL MD-25 CO2 LASER FOR DERMA./PLASTIC SURGERY | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1060848 | 3000204219 | LASER ENGINEERING, INC. | 475 Metroplex Dr Ste 401, Nashville, TN 37211 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
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