# K103415: Tanda Max

- Pathway: 510(k) (Traditional)
- Applicant: Pharos Life Corporation
- Decided: Jan 3, 2011 after 42 days
- Product code: ONE (Powered Light Based Non-Laser Surgical Instrument)
- 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: 10 generations back to K943450 (1995). 85 ancestors in all.
No later device cites it as a predicate yet.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051255: Lumiphase-R, Opusmed, Inc. (2005) Summary page 1.

## Indications for use
The Tiinda Max System is intended for the treatment of wrinkles, rhytides and fine lines in the periorbital region.

Source page: https://510kreport.com/device/K103415
Methodology: https://510kreport.com/methodology