Trinity Ele
510(k) K131251
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131251 | Date1 Oct 2013 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- NFO
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Trinity Ele is a Transcutaneous Electrical Stimulator for Aesthetic Purposes, designed to deliver microcurrent therapy to the skin. It is classified as a Class II medical device under FDA regulations and is intended for non-invasive cosmetic applications, such as skin rejuvenation and reduction of fine lines or wrinkles. The device operates by applying low-level electrical currents to stimulate cellular activity and promote collagen production.
This device is supplied as a reusable, non-sterile medical instrument and is intended for use in professional aesthetic settings, such as dermatology clinics or spas. It is regulated under FDA 510(k) clearance (K131251) with a decision date of October 1, 2013, and is categorized under the Neurology advisory committee for procedural classification. No MRI safety information or specific sterility requirements beyond standard non-sterile device handling are indicated in the data.
Other devices from Carol Cole Company
Questions
AI-generated answers, 19 Sep 2026
What types of professional settings is the Trinity Ele intended for use in and why?
The Trinity Ele is designed for use in professional aesthetic settings such as dermatology clinics or spas. This is because it is classified as a reusable, non-sterile medical device intended for non-invasive cosmetic applications like skin rejuvenation and fine line reduction, which are typically performed in controlled, clinical environments rather than home settings.
Is the Trinity Ele safe for use with MRI machines, and if not, why?
The Trinity Ele’s safety for MRI use is not explicitly addressed in the provided data. Since it is a transcutaneous electrical stimulator, it may contain metallic components or conductive materials that could pose risks in an MRI environment, such as heating or interference. Clinicians should verify compatibility with their MRI facility’s guidelines before use.
How many different models or variations of the Trinity Ele are available, and what does this mean for purchasing?
The Trinity Ele is associated with multiple registration numbers (listed in the data), which may correspond to different models or configurations. These variations could include differences in electrode types, intensity settings, or other technical specifications. Buyers should confirm the exact model and its intended features with the manufacturer to ensure it meets their clinical or aesthetic needs.
Why is the Trinity Ele considered reusable, and what maintenance or cleaning steps should be followed?
The Trinity Ele is classified as a reusable device, which means it is designed for multiple uses in professional settings. Since it is non-sterile, proper cleaning and maintenance are essential to prevent contamination and ensure safe, consistent performance. Clinicians should follow manufacturer-recommended protocols for disinfection between uses, typically involving gentle cleaning with approved disinfectants and avoiding harsh chemicals that could damage the device.