510(k) K201107
K201107 is an FDA 510(k) premarket notification submitted by Gtg Wellness Co., Ltd. for the device "Opera Lebody (Gold), Opera Lebody (Zafiro)". The FDA issued a decision of Substantially Equivalent on Jun 22, 2020. The device falls under product code OHS (Light Based Over The Counter Wrinkle Reduction), a Class II device regulated under 21 CFR 878.4810.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 22, 2020
- Date Received
- Apr 24, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Based Over The Counter Wrinkle Reduction
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
- 510(k)
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.