I-Lipo, Models A00-1238 (230V), A00-1239 (120V)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K101366 ↗

FDA Product Code

NUV

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Chromolite Ep

  Class II

  FDA 510(k) K081619 Active Cleared 18 Jul 2008

• I-Lipo System

  Class II

  FDA 510(k) K111501 Active Cleared 23 Mar 2012

• What is the primary purpose of the I-LIPO device, and how does it differ from traditional massagers?

  The I-LIPO is designed for temporary relief of minor muscle aches and pain by combining suction therapy with light-induced heating. Unlike traditional massagers that rely solely on mechanical pressure, it adds controlled thermal stimulation to promote localized relaxation and improve circulation in soft tissues, making it suitable for both home and clinical use.

• Is the I-LIPO device single-use or reusable, and what does that mean for maintenance?

  The I-LIPO is explicitly labeled as a reusable, non-sterile medical instrument. This means it can be used multiple times but should be cleaned and maintained according to manufacturer guidelines to ensure hygiene and longevity. Unlike single-use devices, it requires proper care to prevent contamination between uses.

• What voltage options are available for the I-LIPO, and how does this affect its global usability?

  The I-LIPO is available in two voltage variants: A00-1238 (230V) and A00-1239 (120V), making it compatible with electrical systems in regions like Europe (230V) and North America (120V). This dual-voltage design ensures broader usability without requiring additional adapters for power supply.

• How should the I-LIPO be stored, and are there any special considerations for its components?

  Since the I-LIPO is reusable and non-sterile, it should be stored in a clean, dry environment to prevent damage or contamination. The device’s components (e.g., suction cups, heating elements) may require periodic inspection for wear or damage. Always follow the manufacturer’s instructions for storage to maintain performance and safety.

• What regulatory pathway was followed for the I-LIPO, and what does this mean for its use in clinical settings?

  The I-LIPO was cleared through the FDA 510(k) process (K101366) as a Class II device under the product code NUV, with a decision labeled as *Substantially Equivalent*. This clearance indicates it meets FDA standards for safety and effectiveness as a Vacuum Massager with Light-Induced Heating, allowing its use in clinical settings where such devices are permitted. However, specific protocols for clinical application should align with local healthcare regulations.