FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIOLASE 10S
K Number: K121327
·
Decision Feb 1, 2013
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
31
Review Days
275
Basic Information
- Device Name
- DIOLASE 10S
- K Number
- K121327
- 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
- BIOLASE TECHNOLOGY, INC.
- Date Received
- May 2, 2012
- Decision Date
- February 1, 2013
- 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 BIOLASE TECHNOLOGY, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K122368 | WATERLASE IPLUS ALL TISSUE LASER | May 2, 2013 | Substantially Equivalent |
| K130465 | EPIC 10S | Apr 11, 2013 | Substantially Equivalent |
| K121286 | EPIC 10 | Sep 28, 2012 | Substantially Equivalent |
| K101658 | WATERLASE MD TURBO PLUS MODEL 7200XXX | Aug 11, 2010 | Substantially Equivalent |
| K093852 | EZLASE 3 LASER SYSTEM | Mar 12, 2010 | Substantially Equivalent |
| K091746 | WATERLASE MD, MODEL 7100102 | Dec 7, 2009 | Substantially Equivalent |
| K083927 | WATERLASE MD | Oct 1, 2009 | Substantially Equivalent |
| K091922 | WATERLASE C100, MODEL 7100104 | Jul 14, 2009 | Substantially Equivalent |
| K083595 | EZLASE | Apr 14, 2009 | Substantially Equivalent |
| K090181 | WATERLASE MD | Feb 11, 2009 | Substantially Equivalent |