# K120513: Glow by Endymed

- Pathway: 510(k) (Traditional)
- Applicant: Endymed Medical, Ltd.
- Decided: May 8, 2012 after 77 days
- Product code: OUH (Skin Resurfacing Rf Applicator)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K943450 (1995). 254 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 260 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083461: Imagine TC Skin Therapy System, Endymion Medical, Ltd. (2009) Summary page 3.
- K101510: Fractional Skin Resurfacing (FSR) Applicator, Endymed Medical, Ltd. (2011) Summary page 3.

## Most influential descendants
- K121150: Alma Lasers Family of Pixel RF Tips (2012), 3 descendants of its own
- K201520: The Alma Opus System, Colibri Applicator and Tips (2021), 1 descendant of its own
- K233760: Mjolnir Pro. (Multi–electrode plasma) (2024), 0 descendants of its own
- K160075: Accent XL (2016), 0 descendants of its own
- K141507: Two Skin Treatment System (2014), 0 descendants of its own

## Indications for use
The Glow by EndyMed is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The TC applicator is indicated for mild to moderate facial wrinkles and rhytides. The FSR applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin.

Source page: https://510kreport.com/device/K120513
Methodology: https://510kreport.com/methodology