Product Code: EWG
FDA class 2
21 CFR 874.4500
Laser, Ent Microsurgical Carbon-Dioxide
Ear, Nose, Throat
The ENT microsurgical carbon-dioxide laser is a surgical laser system that uses CO2 laser energy to precisely incise, ablate, or vaporize soft tissue in the larynx, trachea, and other ENT structures with minimal collateral damage. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is EWG, regulated under 21 CFR 874.4500 in the Ear, Nose, Throat specialty. This device is eligible for third-party review.
510(k)s
24
FEI Numbers
0
Registration Numbers
0
Unique Applicants
14
Years Active
12
Research product code EWG in seconds
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Basic Information
- Product Code
- EWG
- Device Class
- FDA class 2
- Regulation Number
- 874.4500
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 24 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K924652 | BENSON CCA100 | Apr 09, 1993 | Substantially Equivalent | Benson Medical Instruments Co. |
| K870587 | LASERMATIC SURGILASER MODEL 5050 | Aug 10, 1988 | Substantially Equivalent for Some Indications | Lasermatic OY |
| K880429 | ILLUMINA 55 CO2 LASER SYSTEM | Apr 18, 1988 | Substantially Equivalent | Cooper Lasersonics, Inc. |
| K880428 | ILLUMINA 25 CO2 LASER SYSTEM | Apr 18, 1988 | Substantially Equivalent | Cooper Lasersonics, Inc. |
| K880427 | ILLUMINA 40 CO2 LASER SYSTEM | Apr 18, 1988 | Substantially Equivalent | Cooper Lasersonics, Inc. |
| K872710 | MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT | Sep 24, 1987 | Substantially Equivalent | Directed Energy, Inc. |
| K870840 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH | Jun 12, 1987 | Substantially Equivalent | Directed Energy, Inc. |
| K864975 | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT) | Feb 25, 1987 | Substantially Equivalent | Laserscope |
| K862866 | MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE | Jan 09, 1987 | Substantially Equivalent | Directed Energy, Inc. |
| K862865 | MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE | Jan 09, 1987 | Substantially Equivalent | Directed Energy, Inc. |
| K862150 | MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) | Sep 04, 1986 | Substantially Equivalent for Some Indications | Directed Energy, Inc. |
| K862005 | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER | Aug 29, 1986 | Substantially Equivalent | Laserscope |
| K860975 | MODEL 545-45 LASER FOR EAR, NOSE & THROAT | Jul 18, 1986 | Substantially Equivalent | Britt Corp., Inc. |
| K860277 | MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT | May 06, 1986 | Substantially Equivalent | Britt Corp., Inc. |
| K854471 | PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T | Feb 13, 1986 | Substantially Equivalent | Minnesota Laser Corp. |
| K853902 | ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY | Jan 09, 1986 | Substantially Equivalent | Endo Lase, Inc. |
| K853875 | ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY | Jan 09, 1986 | Substantially Equivalent | Endo Lase, Inc. |
| K852695 | FOR USE IN EAR; NOSE & THROAT MICROSURGERY | Aug 30, 1985 | Substantially Equivalent | Minnesota Laser Corp. |
| K843514 | MINUTEMAN CO2 MICROSURGICAL LASER OTO | Dec 04, 1984 | Substantially Equivalent | American Surgical Laser, Inc. |
| K841860 | CO2 SURGICAL LASER SYSTEM XML-10 | Nov 08, 1984 | Substantially Equivalent | Xanar, Inc. |
| K820535 | LASER GAS MIXTURES | Mar 31, 1982 | Substantially Equivalent | Union Carbide Corp. |
| K810740 | ARGON MICROSURIGAL PROTOCOLS | Aug 21, 1981 | Substantially Equivalent | Lumenis, Inc. |
| K802279 | VIDA 55 PULSE-ECHO ULTRASONIC DEVICE | Dec 15, 1980 | Substantially Equivalent | Vida, Inc. |
| K802034 | CO2 MICROSURGICAL LASER SYSTEM #370 | Oct 10, 1980 | Substantially Equivalent | Metricon, Ltd. |