FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LightForce LTS Model 1000, 1500, 2500, and 4000
K Number: K173067
·
Decision Feb 22, 2018
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
7
Review Days
146
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Basic Information
- Device Name
- LightForce LTS Model 1000, 1500, 2500, and 4000
- K Number
- K173067
- 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
- Litecure, LLC
- Date Received
- September 29, 2017
- Decision Date
- February 22, 2018
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Litecure, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K123014 | LITECURE THERAPY SYSTEM MODEL LTS-1500 | Mar 29, 2013 | Substantially Equivalent |
| K123031 | BWF-5 MEDICAL LASER SERIES | Dec 3, 2012 | Substantially Equivalent |
| K121487 | LITECURE THERAPY COMPACT | Jun 12, 2012 | Substantially Equivalent |
| K103511 | LITECURE THERAPY SYSTEM | Jan 25, 2011 | Substantially Equivalent |
| K093087 | BWF-5 MEDICAL LASER SERIES | May 12, 2010 | Substantially Equivalent |
| K070400 | LC THERAPY, MODEL LCT-1000 | Feb 28, 2007 | Substantially Equivalent |