EWG · Class II · 21 CFR 874.4500

FDA Product Code EWG: Laser, Ent Microsurgical Carbon-dioxide

Leading manufacturers include Directed Energy, Inc., Cooper Lasersonics, Inc. and Laserscope.

24
Total
24
Cleared
123d
Avg days
1980
Since

FDA 510(k) Cleared Laser, Ent Microsurgical Carbon-dioxide Devices (Product Code EWG)

24 devices
1–24 of 24
Cleared Apr 18, 1988
ILLUMINA 40 CO2 LASER SYSTEM
K880427
Cooper Lasersonics, Inc.
Ear, Nose, Throat · 77d
Cleared Apr 18, 1988
ILLUMINA 25 CO2 LASER SYSTEM
K880428
Cooper Lasersonics, Inc.
Ear, Nose, Throat · 77d
Cleared Apr 18, 1988
ILLUMINA 55 CO2 LASER SYSTEM
K880429
Cooper Lasersonics, Inc.
Ear, Nose, Throat · 77d
Cleared Sep 24, 1987
MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT
K872710
Directed Energy, Inc.
Ear, Nose, Throat · 79d
Cleared Jun 12, 1987
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH
K870840
Directed Energy, Inc.
Ear, Nose, Throat · 106d
Cleared Feb 25, 1987
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT)
K864975
Laserscope
Ear, Nose, Throat · 65d
Cleared Jan 09, 1987
MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE
K862865
Directed Energy, Inc.
Ear, Nose, Throat · 164d
Cleared Jan 09, 1987
MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE
K862866
Directed Energy, Inc.
Ear, Nose, Throat · 164d
Cleared Sep 04, 1986
MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)
K862150
Directed Energy, Inc.
Ear, Nose, Throat · 92d
Cleared Aug 29, 1986
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER
K862005
Laserscope
Ear, Nose, Throat · 94d
Cleared Jan 09, 1986
ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY
K853875
Endo Lase, Inc.
Ear, Nose, Throat · 114d
Cleared Jan 09, 1986
ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY
K853902
Endo Lase, Inc.
Ear, Nose, Throat · 111d
Cleared Mar 31, 1982
LASER GAS MIXTURES
K820535
Union Carbide Corp.
Toxicology · 29d
Cleared Aug 21, 1981
ARGON MICROSURIGAL PROTOCOLS
K810740
Lumenis, Inc.
Ear, Nose, Throat · 155d

About Product Code EWG - Regulatory Context