FDA.reportPublic FDA data

LASER ENGINEERING, INC.

Matched from indexed company URL: LASER ENGINEERING

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10608483000204219LASER ENGINEERING, INC.1N2026-01-01475 Metroplex Dr Ste 401 Nashville TN US 37211

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860011139706Laser Engineering - Re-usable fiberoptic handpiece for lasers5085202552r.rudko@laserengineering.com
00866988000216UltraLase Flexible Laser Waveguide - This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient.5085202552r.rudko@laserengineering.com
00866988000230Imperium - CO2 Laser Waveguide - 500 microns(508) 520-2500customerinfo@laserengineering.com
00866988000261UltraLase Flexible Laser Waveguide - This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient.(508)520-2500customerinfo@laserengineering.com
00866988000285Laser Engineering - This device is an internally coated fusee silica waveguide used to deliver CO2 laser energy to the patient.5085202500customerinfo@laserengineering.com
00866988000292Laser Engineering - This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient.5085202500customerinfo@laserengineering.com
10866988000213UltraLase Flexible Laser Waveguide - This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient.5085202552r.rudko@laserengineering.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
515291220598836P950015THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATIONMNO1998-08-20
515291488615341K881588MODEL MD-25 LASER FOR SURGICAL USEGEX1988-06-03
515291593637223K881587MODEL MD-25 CO2 LASER FOR PODIATRY APPLICATIONSGEX1988-06-03
515292050085430K881586MODEL MD-45 CO2 LASER FOR ENT APPLICATIONSGEX1988-06-03
515291528641955K881585MODEL MD-25 CO2 LASER FOR NEUROSURGERY USEGEX1988-06-03
515291799079942K881584MODEL MD-45 CO2 LASER FOR NEUROSURGERY USEGEX1988-06-03
515291282946268K881583MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROATGEX1988-06-03
515291130679990K881582MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USEGEX1988-06-03
515291910012496K881581MODEL MD-45 CO2 LASER FOR OB-GYN & UROLOGICAL USEGEX1988-06-03
515291386153206K881580MODEL MD-25 CO2 LASER FOR DERMA./PLASTIC SURGERYGEX1988-06-03
515291523003491K211605Dual SwitchGEX2022-09-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX102022-09-22
MNO11998-08-20

PMA#

PMN#

GUDID#