# K161043: Profound System

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Candela Corporation
- Decided: Sep 12, 2016 after 152 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- 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: 20 generations back to K943450 (1995). 315 ancestors in all.
No later device cites it as a predicate yet.
0 of 316 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082391: Primaeva Medical Renesis System, Primaeva Medical, Inc. (2009) Summary page 4.
- K080145: Primaeva Medical System, Primaeva Medical, Inc. (2008) Summary page 4.
- K150035: V10 system, Viora, Ltd. (2015) Summary page 4.

## Indications for use
The Profound System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Specifically, the 25º Dermal handpiece and cartridge are used for percutaneous treatment of facial wrinkles, and the 75º SubQ handpiece and cartridge are used to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III as supported by long-term clinical data (6 months).

Source page: https://510kreport.com/device/K161043
Methodology: https://510kreport.com/methodology