FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPHOTAS CELLUMA
K Number: K131113
·
Decision Jan 15, 2014
Classifications
1
FEI Numbers
462
Registration Numbers
462
Same Product Code
228
Applicant Total
6
Review Days
268
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Basic Information
- Device Name
- BIOPHOTAS CELLUMA
- K Number
- K131113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biophotas, Inc.
- Date Received
- April 22, 2013
- Decision Date
- January 15, 2014
- Product Code
- ILY
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | FDA class 2 | Physical Medicine |
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Other Clearances by Biophotas, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232977 | Biophotas Celluma CONTOUR | Nov 21, 2023 | Substantially Equivalent |
| K211038 | Biophotas Celluma RESTORE | Jun 29, 2021 | Substantially Equivalent |
| K171323 | BIOPHOTAS CELLUMA3 | Sep 1, 2017 | Substantially Equivalent |
| K152280 | BioPhotas Celluma3 | Mar 2, 2016 | Substantially Equivalent |
| K122237 | BIOPHOTAS LIFELIGHT | Jan 3, 2013 | Substantially Equivalent |