# K060216: Energist Ultra VPL Intense Pulse Light System

- Pathway: 510(k) (Traditional)
- Applicant: Energist, Ltd.
- Decided: Mar 16, 2006 after 48 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: 7 generations back to K910422 (1992). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040659: Mccue PLC Energist Ultra Variable Pulsed Light System, Mccue Plc (2004) Summary page 1.
- K050165: Modification to Ifl Professional System, Model C100, Cyden Limited (2005) Summary page 1.

## Indications for use
The Energist ULTRA Th VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions. Intense Pulsed Light Energy / wavelengths (530 - 950nm) The 530 - 950nm intense pulsed wavelengths are indicated for: The treatment of mild to moderate inflammatory Acne Vulgaris. The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, facial veins and venous malformations. Intense Pulsed Light Energy / wavelengths (610- 95Ohm) The 610 - 950nm intense pulsed wavelengths are indicated for: The removal of unwanted hair from all skin types and to effect stable long-term or permanent ' hair reduction in skin types I - V through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

Source page: https://510kreport.com/device/K060216
Methodology: https://510kreport.com/methodology