FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM
K Number: K053087
·
Decision Mar 1, 2006
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
7
Review Days
119
Basic Information
- Device Name
- VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM
- K Number
- K053087
- 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
- BIOTEX, INC.
- Date Received
- November 2, 2005
- Decision Date
- March 1, 2006
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
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 BIOTEX, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K161704 | Phasor Drill | Dec 1, 2016 | Substantially Equivalent |
| K092197 | PHOTEX30 DIODE LASER SERIES: 980, 810, 940 | Oct 6, 2009 | Substantially Equivalent |
| K081656 | VISUALASE THERMAL THERAPY SYSTEM | Sep 10, 2008 | Substantially Equivalent |
| K071328 | VISUALASE THERMAL THERAPY SYSTEM | Aug 31, 2007 | Substantially Equivalent |
| K063505 | VISUALASE ENVISION SOFTWARE SYSTEM | Dec 12, 2006 | Substantially Equivalent |
| K060304 | PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 | Mar 21, 2006 | Substantially Equivalent |