# K090831: Tanthera-T35

- Pathway: 510(k) (Traditional)
- Applicant: Tanthera, Inc.
- Decided: May 29, 2009 after 64 days
- Product code: LEJ (Booth, Sun Tan)
- Device class: 2
- Regulation: 21 CFR 878.4635
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K800744 (1980). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K800744: Suntana Sunbed #SB-1 & Sunbrella #SU-1, Sun Ind., Inc. (1980) Summary page 3.
- (no number) Philips TL10 UVA1 lamp: named in the summary without a submission number

## Indications for use
Intended to provide ultraviolet light to tan the skin.

Source page: https://510kreport.com/device/K090831
Methodology: https://510kreport.com/methodology