# K163329: Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72

- Pathway: 510(k) (Traditional)
- Applicant: Pulsaderm, LLC
- Decided: Apr 14, 2017 after 137 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- 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). 92 ancestors in all.
106 later devices descend from it; 3 cite it directly.
0 of 199 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140471: Pro X Otc 5, La Lumiere, LLC (2015) Summary page 4.
- K130225: Quasar C100, Baby Quasar Plus, Quasar MD Plus; Wrinkle Reduction Device, Silverbay, LLC, D/B/A Quasar Bio-Tech (2013) Summary page 4.

## Most influential descendants
- K170984: LG Beauty Led Mask (2017), 93 descendants of its own
- K191629: faceLITE (2019), 71 descendants of its own
- K171323: Biophotas CELLUMA3 (2017), 56 descendants of its own
- K183671: LG Pra.L Derma Led Mask (2019), 48 descendants of its own
- K200983: Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine (2021), 46 descendants of its own

## Indications for use
The Pulsaderm Wrinkle Mask 28 and 72 are intended for the use in the treatment of facial wrinkles and for people with Fitzpatrick Skin Types I, II and/or III.

Source page: https://510kreport.com/device/K163329
Methodology: https://510kreport.com/methodology