FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ME HAIR2GO
K Number: K121598
·
Decision Oct 12, 2012
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
73
Applicant Total
35
Review Days
134
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ME HAIR2GO
- K Number
- K121598
- 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
- Syneron Medical, Ltd.
- Date Received
- May 31, 2012
- Decision Date
- October 12, 2012
- Product Code
- ONF
- 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 |
|---|---|---|---|
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ONF), ordered by most recent decision date.
Intense Pulsed Light Therapy Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Intense Pulsed Light Therapy Device (MMABM-1)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDILIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IPL Treatment Device (MDSQMC-01)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEKA LOTUS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Intense Pulsed Light Treatment System (LK-PT)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Syneron Medical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K170370 | ULTRASHAPE POWER SYSTEM | May 15, 2017 | Substantially Equivalent |
| K163415 | SlimShape System | Apr 20, 2017 | Substantially Equivalent |
| K162163 | UltraShape System | Nov 17, 2016 | Substantially Equivalent |
| K161952 | UltraShape System | Nov 7, 2016 | Substantially Equivalent |
| K160896 | ULTRASHAPE POWER SYSTEM | Jul 8, 2016 | Substantially Equivalent |
| K151655 | CO2RE System | Sep 15, 2015 | Substantially Equivalent |
| K141507 | TWO SKIN TREATMENT SYSTEM | Dec 8, 2014 | Substantially Equivalent |
| K141708 | ULTRASHAPE SYSTEM | Oct 6, 2014 | Substantially Equivalent |
| K133238 | CONTOUR I V3.1 SYSTEM | Apr 10, 2014 | Substantially Equivalent |
| K120510 | TRANSCEND | Jul 19, 2013 | Substantially Equivalent |