Light Amplification by the Stimulated Emission of Radiation, widely known as Laser technology, was first introduced in 1960 and it has far-flung applications in various industries including the medical field.
The laser-based products, available in various sizes, shapes and forms, have a laser system that stores and releases the energy from sources such as electrical charge or optical illumination or chemical reaction as light. Laser light in contrast to ordinary light has a specific wavelength, amplification of this specific wavelength and is a narrow beam of light focussed in one direction. All these features result in a light that is concentrated in a small area and can create a very high intensity light at farther distances from the source.
Its use in the medical industry varies from diagnosis of an underlying health condition for the treatment to life-threatening cancer disease. Its application in the fields of ophthalmology, cosmetics and dentistry has been resourceful for practitioners. Medical lasers are medical devices that use precisely focussed light sources to treat or remove tissues.
In the US, both medical and non-medical lasers are regulated by the FDA. The non-medical laser products are categorised and regulated under the radiological products category. Medical lasers are considered as medical devices and they comply with the requirements of both radiology products as well as devices. FDA recognises four major hazard classes (I to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb). This nomenclature is different from the International Electrotechnical Commission classification system. However, in either of them, the higher class corresponds to a more powerful laser and has greater potential to pose serious injury, if not used properly. Hence the labelling of Classes II-IV must include a warning symbol stating the class and output power of the LASER product. The medical lasers are categorised under Class IV and they are considered as high-risk radiological products by the US FDA.
Table 1. The US FDA Classification of LASER Products as a Radiological Product
Various laws, regulations, and standards are applicable to the laser devices and mandate the manufacturer to ensure certain engineering controls and risk communication methodologies are applied to manage and mitigate possible biological hazards. The end-users must ensure proper use of the device as per the device labels issued by manufacturers as the failure of the same can lead to a lack of safety and effectiveness of the product.
Medical lasers have diversified applications and are used in various types of surgical procedures such as: –
- Cosmetic surgery: To remove tattoos, scars, stretch marks, sunspots, wrinkles, birthmarks, spider veins or hair
- Refractive eye surgery: To reshape the cornea to correct or improve vision as in LASIK or PRK)
- Dental procedures: Inclusive of endodontic/periodontic procedures, tooth whitening, and oral surgery
- General surgery: Inclusive of tumour removal, cataract removal, breast surgery, plastic surgery and most other surgical procedures.
Figure 1. Aesthetic Applications of LASER Devices
The laser surgical devices used in dermatology for general and plastic surgeries are regulated under 21 CFR Part 878.4810. There are various laser devices under different product codes used for aesthetic purposes.
Table 2. Product Codes for Aesthetic LASER Medical Devices
Manufacturers of aesthetic laser medical devices must comply with the regulations for Radiological Health i.e., Title 21 CFR (Subchapter J, Radiological Health) Parts 1000 through 1005 and the medical device regulations.
Table 3. Applicable Regulations for Radiological Health
The aesthetic laser medical devices with medical applications must in addition to the above regulations, comply with the device regulations and consensus standards applicable for a given device product code.
Table 4. Consensus Standards for LASER Devices
The majority of LASER devices used for aesthetic purposes are considered as moderate-risk devices, requiring compliance with special controls and a 510(k) clearance from the FDA for importing and marketing the device in the USA. Very few devices fall under Class I requiring compliance with general controls and few devices falling under Class III require a Pre-Market Approval (PMA) from the FDA. The labels of medical laser shall comply with 21 CFR 801 and 21 CFR 1040.10 & 1040.11, Performance Standard for Light Emitting Products.
It is critical to evaluate the intended use of the device and map them to the right regulations. For example, when not labelled or represented as sterile, laser for disruption of adipocyte cells for aesthetic use, classified under PKT, is GMP exempt and 510(k) registration. The device, however, shall comply with general requirements concerning records (820.180) and complaint files (820.198).
The fat reducing low-level laser systems for aesthetic use are classified under product code OLI and regulated under 21 CFR 878.5400. They fall under Class II and shall comply with the special controls issued by the FDA for assured safety and effectiveness of the device and shall obtain the 510(k) approval for importation and distribution of the device within the US market. These are low-level laser systems 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. The US FDA requirements for this device have been detailed below.
The manufacturer shall identify all the components of the device systems including system software and accessories. Photograph or drawing of the device, functional block diagram of the device along with its accessories, predicate comparison sheet; risk profile of the device covered in the risk assessment document shall be submitted to the FDA as a part of the 510(k) technical file. The ocular injury, electrical shock and unintended cell damage and use errors are the common risks involved in these devices used for fat reduction. The manufacturers can choose to justify the risk profile by adopting various mitigation measures such as bench testing, software validation, clinical testing, biocompatibility testing, labelling, and ensuring that the device is in compliance with IEC 60601-1 and IEC 60601-1-2.
Table 5. Risk Mitigation Strategies for Fat Reducing, Low Level, Laser Aesthetic Device
Once the FDA approval/clearance is obtained, all the electronic products are subjected to achieve compliance for 21 CFR 1000-1050. Accordingly, the manufacturers of all the different classes of lasers must submit “Product Reports” (Also called as Radiation Safety Product Report) to the FDA, as per 21 CFR 1002, before the product is introduced into interstate commerce. Once a Product Report is submitted to the FDA, an Accession number is issued by the FDA for the device. Including the accession number is mandatory in the Customs Clearance Form and is usually verified by the US Customs during the importation of the product. If your product is made in another country for import into the United States, the import clearance process requests identification of the accession number on the import affirmation form, FDA 2877.
It is recommended by the FDA to submit the “Periodic Safety reports” at least one month before the product is imported into the US. The manufacturers have varied options to compile and submit the product reports. Product reports can be compiled using Form 3632 /one can compile the product reports using the e-submitter software available on the FDA website. Once an e-copy is generated, the e-copy of the file is usually exported as an XML document which can be submitted to the CDRH directly through ESG Gateway/alternatively the e-submitter can load the XML file onto a CD and can be mailed to CDRH or emailed to RadHealthCustomerService@fda.hhs.gov for processing and issuance of accession number. Reports prepared and submitted using e-submitter software may be acknowledged significantly faster than a traditional report submitted on paper. For faster acknowledgement of the receipt of the product report within 48 hours, the ESG Gateway can be used for product report submission.
In addition to product reports, the manufacturers shall submit duly filled Form 3636/use e-submitter tool to compile the annual reports on radiation safety testing of the devices by September 1st of each year.
Furthermore, EU MDR has broadened the definition of medical devices and more products such as epilation lasers are classified as medical devices. Products listed under Annex XVI make aesthetic claims or other non-medical purposes, but they are very similar to medical devices in terms of safety and risk profile. High-intensity electromagnetic radiation emitting equipment such as lasers and intense pulsed light equipment intended for skin resurfacing, tattoo or hair removal or other skin treatment are considered as medical devices. This might be overwhelming for the companies with medical device portfolios, as the EU MDR requirements could be all new to them. Such companies can start by appointing a Regulatory outsourcing partner and finding the right Notified Body for certification. The laser surgical instrument falls under Class IIb as per the classification rules defined in Chapter III rule 9 of the EU Medical Device Regulations. The manufacturers shall develop the EU MDR compliant device documentation, comply with ISO 13485:2016 followed by conformity assessment of the device by the Notified Body and for CE certification of the device.
In China, powered laser surgical instrument used in dermatology and surgery and intended to remove unwanted brown spots, sun freckles, or tattoos from the skin is classified as Class III.
In a nutshell, the Laser products intended for medical use fall under the purview of multiple regulations and will be under the vigilance of various offices. Navigating through the regulations and framing the right regulatory strategy requires a thorough understanding of the device technologies as well as applicable regulations.
