FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM
K Number: K093251
·
Decision Oct 29, 2009
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
14
Review Days
13
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Basic Information
- Device Name
- OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM
- K Number
- K093251
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Omniguide, Inc.
- Date Received
- October 16, 2009
- Decision Date
- October 29, 2009
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Omniguide, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K203241 | OmniGuide BeamPath OTO-U Fiber | Jan 14, 2021 | Substantially Equivalent |
| K183199 | TRIO Handpiece | May 2, 2019 | Substantially Equivalent |
| K180993 | Beacon Advanced CO2 Laser System | Jun 28, 2018 | Substantially Equivalent |
| K140378 | FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT | Sep 25, 2014 | Substantially Equivalent |
| K093451 | OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP | Nov 20, 2009 | Substantially Equivalent |
| K081939 | OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY | Aug 12, 2008 | Substantially Equivalent |
| K073313 | MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP | Jan 2, 2008 | Substantially Equivalent |
| K073409 | OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM | Dec 14, 2007 | Substantially Equivalent |
| K070157 | OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER | Feb 1, 2007 | Substantially Equivalent |
| K070071 | OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER | Jan 25, 2007 | Substantially Equivalent |