FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ERCHONIA EMERGE
K Number: K130996
·
Decision Sep 16, 2013
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
53
Applicant Total
10
Review Days
159
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Basic Information
- Device Name
- ERCHONIA EMERGE
- K Number
- K130996
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Erchonia Medical, Inc.
- Date Received
- April 10, 2013
- Decision Date
- September 16, 2013
- Product Code
- NHN
- 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 |
|---|---|---|---|
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NHN), ordered by most recent decision date.
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Erchonia FX-405
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Other Clearances by Erchonia Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K153164 | LunulaLaser | Jun 3, 2016 | Substantially Equivalent |
| K132940 | ERCHONIA ALLAY | Apr 14, 2014 | Substantially Equivalent |
| K130922 | ERCHONIA VERJU LASER SYSTEM WITH MASSAGER | May 17, 2013 | Substantially Equivalent |
| K130741 | ERCHONIA PL5000 | Apr 23, 2013 | Substantially Equivalent |
| K120257 | MLS, ZERONA-AD | May 14, 2012 | Substantially Equivalent |
| K072206 | ERCHONIA EML LASER | Apr 24, 2008 | Substantially Equivalent |
| K062792 | ERCHONIA IOTO_240 | Mar 1, 2007 | Substantially Equivalent |
| K050672 | ERCHONIA EVRL LASER | May 2, 2005 | Substantially Equivalent |
| K041139 | ERCHONIA EML LASER | Sep 30, 2004 | Substantially Equivalent |