510(k) K172555
K172555 is an FDA 510(k) premarket notification submitted by Omm Imports, Inc. D/B/A Zero Gravity for the device "SAPPHIRE, ELEVARE SAPPHIRE". The FDA issued a decision of Substantially Equivalent on May 1, 2018. The device falls under product code OLP (Over-The-Counter Powered Light Based Laser For Acne), a Class II device regulated under 21 CFR 878.4810. Omm Imports, Inc. D/B/A Zero Gravity has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2018
- Date Received
- Aug 24, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Over-The-Counter Powered Light Based Laser For Acne
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
- 510(k)
The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.