FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
LG PRA.L DERMA LED MASK
K Number: K183671
·
Decision Jan 22, 2019
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
152
Applicant Total
27
Review Days
26
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Basic Information
- Device Name
- LG PRA.L DERMA LED MASK
- K Number
- K183671
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lg Electronics.Inc
- Date Received
- December 27, 2018
- Decision Date
- January 22, 2019
- Product Code
- OHS
- 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 |
|---|---|---|---|
| OHS | Light Based Over The Counter Wrinkle Reduction | FDA class 2 | General, Plastic Surgery |
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| K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713D | Aug 15, 2023 | Substantially Equivalent |
| K230845 | 32HL512D, 31HN713D, 32HQ713D | Apr 27, 2023 | Substantially Equivalent |
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