# K132833: Ultra Renew Plus

- Pathway: 510(k) (Traditional)
- Applicant: Accord Media
- Decided: Jun 17, 2014 after 280 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
58 later devices descend from it; 3 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Omnilux Clear-U: named in the summary without a submission number
- (no number) Silk'n FX: named in the summary without a submission number
- (no number) Ultrasonic Therapeutic Massager (KUP-300): named in the summary without a submission number

## Most influential descendants
- K142246: LightStim for Acne/ LightStim for Acne Mini (2015), 55 descendants of its own
- K160691: Acne Light Therapy Wand (2016), 50 descendants of its own
- K210948: Omnilux CLEAR (2021), 39 descendants of its own
- K213184: MZ Skin LightMAX Supercharged LED Mask 2.0 (2021), 35 descendants of its own
- K214103: Shani Darden LED light therapy mask (2022), 19 descendants of its own

## Recalls of this device
- Dec 4, 2017 · Class II · Z-0819-2018: Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
- Dec 4, 2017 · Class II · Z-0820-2018: Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
- Dec 4, 2017 · Class II · Z-0822-2018: Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
- Dec 4, 2017 · Class II · Z-0821-2018: Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation

## Indications for use
The Ultra Renew Plus is an over-the-counter device intended: - To emit energy in the red and blue region of the spectrum, specifically to treat mild to moderate acne on the face - To emit energy in the red region of the spectrum for the treatment of periorbital wrinkles. - As an electrically powered device intended for medical purposes to relieve minor aches and pains

Source page: https://510kreport.com/device/K132833
Methodology: https://510kreport.com/methodology