# K161981: Olive Plus

- Pathway: 510(k) (Traditional)
- Applicant: Ama Network, Inc.
- Decided: Oct 14, 2016 after 87 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: 12 generations back to K910422 (1992). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123483: Diode Laser, Beijing Syntech Laser CO., LTD. (2013) Summary page 4.

## Indications for use
Olive Plus Diode Laser device is intended for use in dermatologic and general surgical procedures for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI) including tanned skin Permanent hair reduction is defined as the long term, stable reduction in the number of hairs re-growing when measured at 6, 9,and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K161981
Methodology: https://510kreport.com/methodology