# K172555: Sapphire, Elevare Sapphire

- Pathway: 510(k) (Traditional)
- Applicant: Omm Imports, Inc. D/B/A Zero Gravity
- Decided: May 1, 2018 after 250 days
- Product code: OLP (Over-The-Counter Powered Light Based Laser For Acne)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K943450 (1995). 98 ancestors in all.
52 later devices descend from it; 3 cite it directly.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121435: Silkn Blue, Home Skinovations, Ltd. (2013) Summary page 4.
- K131461: Lightstim for Acne/ Lightstim for Acne Mini, Led Intellectual Properties, LLC (2014) Summary page 4.

## Most influential descendants
- K192295: PDT-Face (2020), 46 descendants of its own
- K202390: Aduro Light Beauty Mask (2021), 39 descendants of its own
- K220168: Skin Care Beauty Mask (Model: MJ-06) (2022), 34 descendants of its own
- K230351: LED Facial Mask (2023), 33 descendants of its own
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (2024), 21 descendants of its own

## Indications for use
The SAPPHIRE is an over –the -counter hand held, battery operated, light therapy device that uses light emitting diodes (LEDs) that emit a specific wavelength of 415nm (Blue Light) that is intended for use in the treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K172555
Methodology: https://510kreport.com/methodology