Energist Ultra VPL Intense Pulse Light System
by Mccue Plc
510(k) K060234
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060234 | Date15 Mar 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Mccue Energist Ultra Vpl Intense Pulse Light System
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Energist Ultra VPL Intense Pulse Light System is a medical device classified as an Intense Pulsed Light (IPL) Device (Product Code: GEX). It delivers controlled pulses of broad-spectrum light to target hair follicles, vascular lesions, and pigmented skin areas for therapeutic effects, including permanent hair reduction and photocoagulation of blood vessels. The device operates by selectively absorbing light energy to induce thermal effects in targeted tissues, aiding in the treatment of mild to moderate inflammatory acne and benign pigmented lesions. Its design leverages variable pulse settings to optimize treatment outcomes across different skin types and conditions.
The Energist Ultra VPL is supplied as a reusable medical device intended for use in clinical settings by trained professionals. It is not sterile upon delivery and requires cleaning and maintenance as specified by the manufacturer. The system is approved under FDA 510(k) clearance (K060234) and is categorized under the General, Plastic Surgery advisory committee. No specific MRI safety classification is stated in the regulatory data. Proper storage and handling are essential to ensure device performance and patient safety.
Other devices from Mccue Plc
Questions
AI-generated answers, 1 Oct 2026
What conditions does the Energist Ultra VPL treat?
The Energist Ultra VPL Intense Pulse Light System targets hair follicles, vascular lesions, and pigmented skin areas. It is clinically indicated for permanent hair reduction, photocoagulation of blood vessels, and mild to moderate inflammatory acne. The device also aids in treating benign pigmented lesions by selectively absorbing light energy to induce controlled thermal effects in targeted tissues.
Is the Energist Ultra VPL reusable or single-use?
The Energist Ultra VPL is designed as a reusable medical device. It is intended for use in clinical settings by trained professionals and requires proper cleaning and maintenance as outlined by the manufacturer to ensure performance and patient safety. Reusability allows for cost-effective use across multiple treatments.
How does the device optimize treatment outcomes?
The Energist Ultra VPL features variable pulse settings, enabling clinicians to customize treatment parameters for different skin types and conditions. This adaptability ensures targeted thermal effects on hair follicles, blood vessels, and pigmented areas, improving efficacy and safety during procedures like hair reduction and vascular lesion treatment.
What storage and handling precautions should be followed?
Proper storage and handling are critical to maintain device performance and patient safety. The Energist Ultra VPL is not sterile upon delivery and must be cleaned and maintained according to the manufacturer’s guidelines. Storage should follow the manufacturer’s recommendations to prevent contamination or damage, ensuring reliability for clinical use.
What regulatory approval does the Energist Ultra VPL hold?
The Energist Ultra VPL Intense Pulse Light System holds FDA 510(k) clearance under the product code GEX, categorized under the General, Plastic Surgery advisory committee. This clearance confirms its substantial equivalence to a predicate device, allowing its use in clinical settings for the specified therapeutic applications.