FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
K Number: K082819
·
Decision Mar 20, 2009
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
64
Applicant Total
4
Review Days
176
Basic Information
- Device Name
- DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
- K Number
- K082819
- 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
- MIRAMAR LABS, INC.
- Date Received
- September 25, 2008
- Decision Date
- March 20, 2009
- Product Code
- NEY
- 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 |
|---|---|---|---|
| NEY | System, Ablation, Microwave And Accessories | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NEY), ordered by most recent decision date.
Microwave Ablation Generator (KY-2000A, KY-2100A)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Microwave Ablation Antennas
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Temperature Sensor Probe (ABL-18TP20)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
swiftPro System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien Remote Temperature Probe (RTP20); Covidien Remote Temperature Probe, Bulk (RTP20B)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery