# K083748: Ipulse, Model: I150

- Pathway: 510(k) (Special)
- Applicant: Cyden Limited
- Decided: Feb 2, 2009 after 47 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The iPulse i150 System is a laser surgical instrument for use in General and Plastic Surgery and Dermatology. The iPulse i150 system emits a wavelength of 530nm to 1200nm and is specifically intended for the long term stable, or permanent, reduction in hair.

Source page: https://510kreport.com/device/K083748
Methodology: https://510kreport.com/methodology