# K080406: Ipulse, Model I400

- Pathway: 510(k) (Special)
- Applicant: Cyden Limited
- Decided: Mar 10, 2008 after 25 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. The FDA summary names no predicate by number.

## Indications for use
The iPulse System is a laser surgical instrument for use in General and Plastic Surgery and Dermatology and specifically for long term stable, or permanent, hair reduction. In addition, the iPulse System is indicated for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions. The iPulse System is indicated for the treatment of mild to moderate inflammatory Acne Vulgaris.

Source page: https://510kreport.com/device/K080406
Methodology: https://510kreport.com/methodology