FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
1 Series Phototherapy Equipment
K Number: K220840
·
Decision Apr 22, 2022
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
271
Applicant Total
15
Review Days
30
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Basic Information
- Device Name
- 1 Series Phototherapy Equipment
- K Number
- K220840
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4630
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Daavlin Distributing Co.
- Date Received
- March 23, 2022
- Decision Date
- April 22, 2022
- Product Code
- FTC
- 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 |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FTC), ordered by most recent decision date.
Phototherapy System (DUV-COMBO)
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Ultraviolet Phototherapy Device
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308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)
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308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
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UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Daavlin Distributing Co.
| K Number | Device Name | ||
|---|---|---|---|
| K233811 | DT Controlled Phototherapy Equipment | Dec 13, 2023 | Substantially Equivalent |
| K230382 | 3 Series NeoLux | Mar 24, 2023 | Substantially Equivalent |
| K212510 | 7 Series Phototherapy Device | Nov 4, 2021 | Substantially Equivalent |
| K210881 | M Series Phototherapy Equipment | Jun 22, 2021 | Substantially Equivalent |
| K151795 | ML24000 UVA-1 Phototherapy Cabinet | Sep 10, 2015 | Substantially Equivalent |
| K110912 | SMART TOUCH UVTHERAPY MULTIPLE MACHINE | Oct 20, 2011 | Substantially Equivalent |
| K111172 | 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES | Aug 29, 2011 | Substantially Equivalent |
| K100628 | PLASMALUXLS | Nov 24, 2010 | Substantially Equivalent |
| K100378 | 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 | Apr 28, 2010 | Substantially Equivalent |
| K082731 | ML24000 UVA-1 PHOTOTHERAPY CABINET | Dec 17, 2008 | Substantially Equivalent |