The Erchonia® SHL Laser is indicated for use as a non-invasive dermatological aesthetic treatment for reduction of circumference of hips, waist and upper abdomen when applied to individuals with a Body Mass Index (BMI) between 30 kg/m² and 40 kg/m².

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the Erchonia® SHL Laser. It does not contain information about acceptance criteria or a study proving device performance in the way a clinical trial report would. It only confirms the device is substantially equivalent to a predicate device for its indicated use.

Therefore, most of the requested information cannot be extracted from the provided text.

However, I can extract the "Indications for Use" which defines for what purpose the device is intended.

Indications for Use: The Erchonia® SHL Laser is indicated for use as a non-invasive dermatological aesthetic treatment for reduction of circumference of hips, waist and upper abdomen when applied to individuals with a Body Mass Index (BMI) between 30 kg/m² and 40 kg/m².

Regarding the requested information, here's what can be stated based only on the provided text:

A table of acceptance criteria and the reported device performance:
- No acceptance criteria or reported device performance are mentioned in this administrative document. The 510(k) clearance is based on substantial equivalence, not a direct clinical performance study detailed here.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not present in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not present in this document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not present in this document.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not present in this document. This device is a laser system, not an AI diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not present in this document. This device is a laser system, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not present in this document. Substantial equivalence relies on comparison to a predicate device, not necessarily a new ground truth determination in the context of this clearance.
The sample size for the training set:
- Not present in this document. This is not an AI/algorithm device that requires a training set in the typical sense.
How the ground truth for the training set was established:
- Not present in this document.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 21, 2014

Erchonia Corporation % Mr. Kevin Walls Regulatory Insight Incorporated 33 Golden Eagle Lane Littleton, Colorado 80127

Re: K142042

Trade/Device Name: Erchonia® SHL Laser Regulation Number: 21 CFR 878.5400 Regulation Name: Low level laser system for aesthetic use Regulatory Class: Class II Product Code: OLI Dated: July 24, 2014 Received: July 28, 2014

Dear Mr. Walls:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K142042

Device Name Erchonia® SHL

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Regulation Number and Section

§ 878.5400 Low level laser system for aesthetic use

(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.