# K071883: Ipulse, Quadra Q4 Platinum Series, Model (S) 1200+Series 2, 1300 Series 2, Q4 Series 2

- Pathway: 510(k) (Special)
- Applicant: Cyden Limited
- Decided: Jan 23, 2008 after 198 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 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/K071883
Methodology: https://510kreport.com/methodology