# K211217: Profound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corporation
- Decided: Dec 16, 2021 after 237 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- 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: 11 generations back to K943450 (1995). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121481: Infini Radiofrequency System, Lutronic Corporation (2013) Summary page 4.

## Indications for use
The PROFOUND MATRIX SYSTEM is intended for dermatological procedures, as follows: The MATRIX PRO applicator is indicated for general dermatological procedures for electrocoagulation and hemostasis. The SUBLATIVE RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62mJ/pin, the Sublative RF applicator is limited to Fitzpatrick Skin Types I-IV. The SUBLIME applicator is indicated for non-invasive wrinkle treatment. At higher energy levels, greater than 100 J/cm3, the Sublime applicator is limited to Fitzpatrick Skin Types I-IV.

Source page: https://510kreport.com/device/K211217
Methodology: https://510kreport.com/methodology