Document issued on: April 14, 2011
For questions regarding this document contact Richard Felten at 301-796-6392 by email at [email protected].
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
General Surgery Devices Branch
Division of Surgical, Orthopedic and Restorative Devices
Office of Device Evaluation
Preface
Public Comment
Written comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Alternatively, electronic comments may be submitted to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. Comments may not be acted upon by the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet. You may also send an email request to [email protected] to receive an electronic copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number 1735 identify the guidance you are requesting.
Table of Contents
- Introduction
- Background
- Scope
- Device Description
Device Components
Photograph or Drawing of the Device
Comparison to the Predicate Device - Risks to Health
- Bench Testing
- Software Validation
- Clinical Testing
- Biocompatibility
- Electromagnetic Compatibility (EMC)
- Electrical and Mechanical Safety Performance Testing
- Labeling
Device User Manual
Directions for Use
Indications for Use
Contraindications
Storage Conditions
Warnings
Precautions
Guidance for Industry and FDA Staff
Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use
1. Introduction
This guidance document was developed as a special control guidance to support the classification of the low level laser system for aesthetic use into class II (special controls). The device is intended to apply low level laser energy to the body to achieve temporary changes in physical appearance. This guidance document is issued in conjunction with a Federal Register notice announcing the classification of the low level laser system for aesthetic use.
Following the effective date of the final rule, manufacturers of devices within this generic type of device will need to address the issues covered in the special control guidance. However, the manufacturer need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. These recommendations are in addition to the requirements that low level laser systems must also meet under 21 CFR 1040, Performance Standards for Light-Emitting Products.1
2. Background
FDA believes that special controls, when combined with the general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of the low level laser system for aesthetic use. Therefore, a manufacturer who intends to market a device of this generic type must (1) conform to the general controls of the Federal Food, Drug Cosmetic Act (the FDC Act), including the premarket notification requirements described in 21 CFR 807 Subpart E, (2) address the specific risks to health associated with the low level laser system for aesthetic use, including those identified in this guidance, and (3) obtain a substantial equivalence determination from FDA prior to marketing the device.
This special control guidance document identifies the classification regulation and product code for the low level laser system for aesthetic use (refer to Section 3. Scope). Other sections of this guidance document list the risks to health FDA has identified and describe measures that, if followed by manufacturers and combined with the general controls, will generally address the risks associated with these low level laser systems and lead to a timely 510(k) review. This document supplements other FDA documents regarding the specific content requirements of a premarket notification submission. You should also refer to 21 CFR 807.87, the guidance, Format for Traditional and Abbreviated 510(k)s2 and the section of CDRH’s Device Advice, How to Prepare a 510(k) Submission.3
3. Scope
The scope of this document is limited to the following class II device (product code OLI) described below.
21 CFR 878.5400 Low Level Laser Systems for Aesthetic Use
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 non-invasive aesthetic use.
Classification. Class II (special controls). The special controls are: 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 21 CFR 878.1(e) for availability of this guidance document.
4. Device Description
We recommend you identify your device using regulation and product code described in Section 3. Scope and include the following:
Device Components
We recommend you identify all components, system software, and accessories within the scope of the 510(k).
Photograph or Drawing of the Device
We recommend you provide a photograph or drawing of the device. We also recommend you provide a functional block diagram (including all accessories).
Comparison to the Predicate Device
We recommend you explain how your device and the predicate are similar, with respect to indications for use and technological characteristics.
5. Risks to Health
In the table below, FDA has identified the risks to health generally associated with the use of the low level laser system for aesthetic use addressed in this document. The measures recommended to mitigate these identified risks are given in this guidance document, as also shown in the table below. You should also conduct a risk analysis before submitting your premarket notification to identify any other risks specific to your device. We recommend the premarket notification describe the risk analysis method and include the results. If you elect to use an alternative approach to address a particular risk identified in this guidance document, or you have identified risks additional to those in the guidance, you should provide sufficient detail to support the approach you have used to address that risk.
6. Bench Testing
We recommend that preclinical testing be performed to demonstrate that the low level laser system for aesthetic use meets all design specification and performance requirements. In regard to laser power and performance, laser power measurements should be conducted and should demonstrate that the laser output power, specifically that reaching the target site, is predictable. Testing should accurately characterize the output beam profile and establish that the laser energy is delivered and concentrated in the desired target location. Testing should demonstrate the accuracy of the method for targeting the region of interest and, if applicable, for monitoring the progress or result of treatment.
Testing should be performed to assess the probability of system failure, the means by which system failure can be mitigated, and the means by which system failure is apparent to the user. The overall system should be tested to ensure proper performance to design specifications and to assess the failure modes and probabilities. Bench testing may also be used to assess the likelihood that the conditions of use may affect system performance.
7. Software Validation
We recommend that you submit the information for software-controlled devices described in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.4 The kind of information we recommend you submit is determined by the “level of concern,†which is related to risks associated with software failure. The level of concern for a device may be minor, moderate, or major. FDA believes that the software used to operate a low level laser for aesthetic use presents a “moderate level of concern†as described in the Software Guidance because a failure or latent design flaw could directly result in minor injury to the patient or operator.
In addition, we recommend that the development of the control software follow IEC 60601-1-4: Medical electrical equipment – Part 1-4; “General Requirements for Safety; Collateral Standard: Programmable electrical medical devices†or equivalent methods.
5 In addition the sponsors of such trials must comply with the regulations governing institutional review boards (21 CFR Part 56) and informed consent (21 CFR Part 50).
9. Biocompatibility
We recommend that you evaluate the biocompatibility of the device as described in the International Organization for Standardization (ISO) standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for intermittent external contact with intact external body surfaces. If identical materials and identical material processing are used in a predicate device with the same type and duration of patient contact, you may identify the predicate device in lieu of performing biocompatibility testing.
10. Electromagnetic Compatibility (EMC)
We recommend that you demonstrate the EMC of the device by performing EMC testing as described in the following FDA-recognized standard or equivalent method.
- IEC 60601-1-2 (Second Edition, 2001) Medical Electrical Equipment – Part 1: General Requirements for Safety; Electromagnetic compatibility – Requirements and Tests
11. Electrical and Mechanical Safety Performance Testing
We recommend that you demonstrate the electrical and mechanical safety of the device by performing electrical and mechanical safety testing as described in the following FDA-recognized standard or equivalent method.
- IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety
12. Labeling
The premarket notification must include labeling in sufficient detail to satisfy the requirements of 21 CFR 807.87(e). The following suggestions are aimed at assisting you in preparing the labeling that satisfies the requirements of 21 CFR Part 801.6
Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s.
Device Advice: Premarket Notification 510(k).
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm089543.htm
http://www.fda.gov/ScienceResearch/SpecialTopics/ RunningClinicalTrials/GuidancesInformationSheetsandNotices/default.htm
6 Although final labeling is not required for 510(k) clearance, final labeling must comply with the requirements of 21 CFR Part 801 before a medical device is introduced into interstate commerce. In addition, final labeling for prescription medical devices must comply with 21 CFR 801.109. Labeling recommendations in this guidance are consistent with the requirements of Part 801.