CO2 Microsurgical Laser System #370

FDA 510(k) K802034 · Metricon, Ltd.

Substantially Equivalent

510(k) numberK802034

Submission

Device name
CO2 Microsurgical Laser System #370
Applicant
Metricon, Ltd.
Walker, MI, US
Received
August 22, 1980
Decision date
October 10, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EWG – Laser, Ent Microsurgical Carbon-Dioxide
Device class
Class II (moderate risk)
Regulation
21 CFR 874.4500
Specialty
Ear, Nose, Throat

Other 510(k)s with product code EWG

510(k)DeviceApplicantDecision
K924652Benson CCA100EWG · Traditional Benson Medical Instruments Co.04/09/1993SE
K870587Lasermatic Surgilaser Model 5050EWG · Traditional Lasermatic OY08/10/1988SN
K880429Illumina 55 CO2 Laser SystemEWG · Traditional Cooper Lasersonics, Inc.04/18/1988SE
K880428Illumina 25 CO2 Laser SystemEWG · Traditional Cooper Lasersonics, Inc.04/18/1988SE
K880427Illumina 40 CO2 Laser SystemEWG · Traditional Cooper Lasersonics, Inc.04/18/1988SE
K872710Model 20-B W/OB-10A/U Attach. for Ear, Nose/ThroatEWG · Traditional Directed Energy, Inc.09/24/1987SE
K870840Model 20-C W/BR-20A/U Attach/Model HL-3.O AttachEWG · Traditional Directed Energy, Inc.06/12/1987SE
K864975Laserscope Omniplus Photosurgical System for (ENT)EWG · Traditional Laserscope02/25/1987SE
K862866Model 10-C W/LP-10A/U & OS-10A/U for Oral/Ent UseEWG · Traditional Directed Energy, Inc.01/09/1987SE
K862865Model 10-C W/LP-10A/U & OB-10A/U for Oral/Ent UseEWG · Traditional Directed Energy, Inc.01/09/1987SE

More from Directed Energy, Inc.

510(k)DeviceDecision
K810562Carbon Dioxide (C02) Microsurgical LaserHHR · Traditional 03/17/1981SE
K802355Metricon #120 FluorophotometerHJO · Traditional 12/17/1980SE

Questions and answers

When was CO2 Microsurgical Laser System #370 cleared by the FDA?

CO2 Microsurgical Laser System #370 (K802034) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 49 days after the submission was received.

What is the product code of K802034?

The FDA product code is EWG – Laser, Ent Microsurgical Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 874.4500.