FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISION ONE LASER SYSTEM
K Number: K111213
·
Decision Jul 25, 2011
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
43
Review Days
84
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Basic Information
- Device Name
- VISION ONE LASER SYSTEM
- K Number
- K111213
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lumenis, Inc.
- Date Received
- May 2, 2011
- Decision Date
- July 25, 2011
- 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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|---|---|---|---|
| K211979 | Lumenis Y&R Laser System | Jun 21, 2022 | Substantially Equivalent |
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| K130195 | SCANNING LASERLINK | Nov 1, 2013 | Substantially Equivalent |
| K100228 | VERSAPULSE MODEL P20 LASER SYSTEM | Feb 24, 2010 | Substantially Equivalent |
| K091962 | POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 | Sep 30, 2009 | Substantially Equivalent |
| K082809 | ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM | Dec 18, 2008 | Substantially Equivalent |
| K081704 | SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS | Sep 11, 2008 | Substantially Equivalent |
| K053628 | LIGHTSHEER DUET LASER SYSTEM | Apr 7, 2006 | Substantially Equivalent |
| K060338 | FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO | Mar 9, 2006 | Substantially Equivalent |
| K052526 | NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES | Nov 15, 2005 | Substantially Equivalent |