# K132431: Thermage CPT System

- Pathway: 510(k) (Special)
- Applicant: Solta Medical, Inc.
- Decided: Sep 6, 2013 after 32 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K943450 (1995). 117 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090580: Thermage Thermacool NXT System and Accessories, Solta Medical, Inc. (2009) Summary page 1.
- K102698: Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve Glidesafe, Ellman Int'L, Inc. (2011) Summary page 1.
- K070004: Accent, Alma Lasers, Ltd. (2007) Summary page 1.
- K072699: Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XL, Alma Lasers, Ltd. (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K111147: Medline Vessel Cannula, Medline Industries, Inc. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K170758: Thermage FLX System and Accessories (2017), 13 descendants of its own
- K230663: Density (2023), 2 descendants of its own
- K221989: The Oligio (2022), 2 descendants of its own
- K173759: Thermage CPT System and Accessories (2018), 2 descendants of its own
- K240248: Volnewmer™ (2024), 1 descendant of its own

## Recalls of this device
- Dec 30, 2019 · Class II · Z-1681-2020: Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns.

## Indications for use
The radiofrequency-energy only delivery components of the Thermage CPT® System and Accessories are Indicated for use in: Dermatologic and General Surgical procedures for electrocoagulation and hemastasis; Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; Non-invasive treatment of wrinkles and rhytids. The simultaneous application of radiofrequency energy and skin vibration by the Thermage CPT® System and Accessories in indicated for use in: Dermatologic and General Surgical procedures for electrocoagulation and hemnostasis; Non-invasive treatment of periorbital wrinkles and rhytids; Non-invasive treatment of wrinkles and rhytids; Temporary improvement in the appearance of celiuhite; Relief of minor muscle aches and pains; Relief of muscle spasms; Temporary improvement of local circulation (i.e., blood circulation).

Source page: https://510kreport.com/device/K132431
Methodology: https://510kreport.com/methodology