FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
SlimShape System
K Number: K163415
·
Decision Apr 20, 2017
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
35
Review Days
136
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
- SlimShape System
- K Number
- K163415
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Syneron Medical, Ltd.
- Date Received
- December 5, 2016
- Decision Date
- April 20, 2017
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoolSeal Generator® (CSL-200-90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROMARK System (NMK00301)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAP-iX2N
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MILAN System
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 |
| 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 |
| K121598 | ME HAIR2GO | Oct 12, 2012 | Substantially Equivalent |