FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇮 Slovenia
LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N
K Number: K121508
·
Decision Dec 12, 2012
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
18
Applicant Total
27
Review Days
205
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Basic Information
- Device Name
- LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N
- K Number
- K121508
- 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
- Fotona D.D.
- Date Received
- May 21, 2012
- Decision Date
- December 12, 2012
- Product Code
- PDZ
- 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 |
|---|---|---|---|
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Fotona D.D.
| K Number | Device Name | ||
|---|---|---|---|
| K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Apr 9, 2015 | Substantially Equivalent |
| K132806 | FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE | Jul 11, 2014 | Substantially Equivalent |
| K113702 | FOTONA XP ND: YAG LASER SYSTEM | Mar 28, 2012 | Substantially Equivalent |
| K101306 | SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A | Jul 1, 2011 | Substantially Equivalent |
| K101817 | LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N | Nov 22, 2010 | Substantially Equivalent |
| K093162 | FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID | Jan 22, 2010 | Substantially Equivalent |
| K090126 | FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2, | Jun 29, 2009 | Substantially Equivalent |
| K083889 | FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY | Apr 23, 2009 | Substantially Equivalent |
| K083034 | FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F | Feb 4, 2009 | Substantially Equivalent |
| K070355 | FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY | Mar 4, 2008 | Substantially Equivalent |