# K043377: ZENO

- Pathway: 510(k) (Traditional)
- Applicant: Tyrell, Inc.
- Decided: Jun 1, 2005 after 175 days
- Product code: GEX (Powered 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: 1 generation back to K982082 (1998). 3 ancestors in all.
142 later devices descend from it; 7 cite it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982082: Handisol Wound Healing, National Biological Corp. (1998) Summary page 4.
- K013623: Clearlight Phototheraphy System, Model CL 420, Curelight, Ltd. (2002) Summary page 4.
- K032205: Radiancy Acne System with Cleartouch Light Unit Assembly, Radiancy (Israel), Ltd. (2003) Summary page 4.

## Most influential descendants
- K080591: Tanda Skincare System, Model: Ptscs (2008), 137 descendants of its own
- K060653: Thermaclear (2006), 132 descendants of its own
- K121435: Silkn Blue (2013), 125 descendants of its own
- K131461: Lightstim for Acne/ Lightstim for Acne Mini (2014), 81 descendants of its own
- K124042: Tanda Mini Skincare System (2013), 76 descendants of its own

## Indications for use
Zeno is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K043377
Methodology: https://510kreport.com/methodology