FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASA 'MPHI FAMILY DIODE LASER
K Number: K111901
·
Decision Nov 9, 2011
Classifications
1
FEI Numbers
462
Registration Numbers
462
Same Product Code
228
Applicant Total
98
Review Days
127
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Basic Information
- Device Name
- ASA 'MPHI FAMILY DIODE LASER
- K Number
- K111901
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cynosure, Inc.
- Date Received
- July 5, 2011
- Decision Date
- November 9, 2011
- Product Code
- ILY
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | FDA class 2 | Physical Medicine |
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| K171111 | Sculpsure | Jun 13, 2017 | Substantially Equivalent |
| K160470 | SculpSure | Jul 21, 2016 | Substantially Equivalent |
| K160480 | PicoSure Workstation | May 17, 2016 | Substantially Equivalent |
| K150724 | SculpSure | Jul 1, 2015 | Substantially Equivalent |
| K150230 | SculpSure | May 15, 2015 | Substantially Equivalent |