(105 days)
The Picosecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery: such as tattoos removal and benign pigmented lesions.
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, blue, green and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Picosecond Nd: YAG Laser Systems, pulse width: < 500ps; pulse energy up to 500mJ, instantaneous emission of laser energy efficient crushing lesions tissue chromophore, that is photon burst: laser accumulation energy is instantaneous emission. The instrument uses the laser-wave to break Chromatophore into pieces which can be naturally absorbed by the body. So that it achieves the purpose of de-freckling. The 1064 nm wavelength will shatter and removes the black, blue, purple and brown pigments while the 532 nm wavelength will shatter and removes red, pink, yellow and orange pigments of the tattoo or other pigmentations without damaging the normal tissue. Apply for tattoo and tattoo epidermal/ dermal lesion pigmented, lesions removal. Picosecond laser is being introduced as the first safe and effective aesthetic laser specifically designed to treat tattoos and pigmented lesions. This innovative laser delivers ultra short pulse bursts of energy to the skin in trillionths of a second. These pulses create a photomechanical effect, that target ink while avoiding unmarked tissue. The pulse shatters the ink into tiny, dust-like particles which are easily eliminated by the body.
This document describes the Smedtrum Medical Technology Co., Ltd. Picosecond Nd:YAG Laser System (K240118) and compares it to a predicate device (K200116).
Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from IEC Standards) | Reported Device Performance (from Bench Testing) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1:2005+A1:2012 | Complies with IEC 60601-1:2005+A1:2012 |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2:2020 | Complies with IEC 60601-1-2:2020 |
| Laser Safety | Compliance with IEC 60825-1:2014 | Complies with IEC 60825-1:2014 |
| Laser Device Performance | Compliance with IEC 60601-2-22:2019 | Complies with IEC 60601-2-22:2019 |
| Laser Energy Output | Within ±20% of specified output | Within ±20% (verified with laser energy meter) |
| Frequency | Consistent with specification | Consistent with specification (Oscilloscope) |
| Pulse Width | Consistent with specification | Consistent with specification (Oscilloscope) |
| Spot Size | Consistent with specification | Consistent with specification (photo paper + ruler) |
| Wavelength | 532 nm and 1064 nm | 532 nm and 1064 nm (Spectrum Analyzer) |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The "testing" primarily refers to bench testing and electrical/software verification. Therefore, no information is available regarding sample size or data provenance (country of origin, retrospective/prospective) for a test set of patient data, as this kind of study was not conducted or reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth based on expert consensus for clinical data was established or reported.
4. Adjudication method for the test set
Not applicable. No adjudication method for clinical data was reported.
5. 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 applicable. This device is a laser system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a standalone hardware medical device (laser system) and does not involve an algorithm with human-in-the-loop performance. The "software verification and validation testing" refers to the control software of the laser system, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the technical performance of the device, the "ground truth" was based on engineering specifications and established international standards (IEC). These standards define acceptable ranges and behaviors for laser energy output, electrical safety, electromagnetic compatibility, and specific laser device performance parameters. The measurements obtained through bench testing were compared against these established standards and specifications.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this device is a laser system and does not utilize machine learning or AI models that require data training.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a "training set" for which ground truth would need to be established.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria primarily consists of engineering and bench testing.
- Electrical safety and electromagnetic compatibility: The device was tested for compliance with recognized international standards: IEC 60601-1 (general requirements for basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), and IEC 60601-2-22 (particular requirements for surgical, cosmetic, therapeutic, and diagnostic laser equipment).
- Laser Safety: Compliance with IEC 60825-1 (safety of laser products, equipment classification and requirements) was verified.
- Software Verification and Validation: Testing was conducted in accordance with FDA's guidance for software in medical devices, considering the software a "moderate" level of concern.
- Bench Testing: This involved instrumental measurements of key laser parameters:
- Laser energy output: Verified within ±20% using a laser energy meter that meets IEC 60825 standards.
- Wavelength: Checked with a Spectrum Analyzer to confirm 532 nm and 1064 nm.
- Frequency and Pulse Width: Measured with an Oscilloscope to ensure consistency with specifications.
- Spot Size: Determined by emitting a laser onto photo paper and measuring the spot size with a ruler.
The conclusion states that "The non-clinical data and performance testing reports in this submission demonstrate that Picosecond Nd:YAG Laser System meets the expected performance requirements." This indicates that the device's performance characteristics, as measured during these tests, fell within the acceptable ranges and standards established for safety and effectiveness.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
April 30, 2024
Smedtrum Medical Technology Co., Ltd. Crimson Wu Senior Regulatory Engineer 1F., No. 8, Ln. 97, Wugong Rd., New Taipei City, Xinzhuang Dist. 248016 Taiwan
Re: K240118
Trade/Device Name: Picosecond Nd:YAG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: March 29, 2024 Received: March 29, 2024
Dear Crimson Wu:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
{2}------------------------------------------------
Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tanisha L. Digitally signed b Tanisha Hithe -S 11:46:33 -04'00
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & Infection Control Devices, Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K240118
Device Name
Picosecond Nd:YAG Laser System
Indications for Use (Describe)
The Picosecond Nd: Y AG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery: such as tattoos removal and benign pigmented lesions.
1064nm wavelength:
-
Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, blue, green and purple.
-
Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
-
Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
-
Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows a logo for Smed Medical Technology. The logo consists of a stylized blue and gray geometric shape on the left, followed by the text "Smed" in a light gray-blue color. Above the word "Smed" is Chinese text, and below it is the text "MEDICAL TECHNOLOGY" in a smaller font.
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan TEL:+886 (02) 2298 9578 FAX:+886 (02) 2298 9426
K240118, 510(k) Summary Picosecond Nd: YAG Laser System
SUBMITTER I.
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016, Taiwan (R.O.C.) Contact Person
Crimson Wu Position: Senior Regulatory Engineer Tel: +886-2-2298-9578, Ext. 301 Fax: +886-2-2298-9426 E-mail: crimsonwu@smedtrum.com Date of preparation: Jan 16th, 2024
II. DEVICE
| Trade Name: | Picosecond Nd:YAG Laser System |
|---|---|
| Common or Usual Name: | Surgical Laser Device |
| Product code: | GEX |
| Regulation Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology |
21 C.F.R. § 878.4810, Device Class II
PREDICATE DEVICE III.
| Manufacturer | Shanghai Apolo Medical Technology Co., Ltd. |
|---|---|
| Trade Name: | PicoSecond Nd: YAG Laser System |
| Common or Usual Name: | Surgical Laser Device |
| Regulation Name: | Laser Surgical Instrument For Use In General AndPlastic Surgery And In Dermatology21 C.F.R. § 878.4810, Device Class II |
| Premarket Notification: | K200116 May 28th, 2020 |
IV. DEVICE DESCRIPTION
Picosecond Nd: YAG Laser Systems, pulse width: < 500ps; pulse energy up to 500mJ, instantaneous emission of laser energy efficient crushing lesions tissue chromophore, that is photon burst: laser accumulation energy is instantaneous emission. The instrument uses the laser-wave to break Chromatophore into pieces which can be
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image contains a logo for a company called "Smedtrum MEDICAL TECHNOLOGY CO.,LTD.". The logo consists of a stylized letter "S" made up of teal-colored triangles on the left side. To the right of the symbol is the company name in both Chinese and English. The English name is in a light gray font.
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan TEL:+886 (02) 2298 9578 FAX:+886 (02) 2298 9426
naturally absorbed by the body. So that it achieves the purpose of de-freckling. The 1064 nm wavelength will shatter and removes the black, blue, purple and brown pigments while the 532 nm wavelength will shatter and removes red, pink, yellow and orange pigments of the tattoo or other pigmentations without damaging the normal tissue. Apply for tattoo and tattoo epidermal/ dermal lesion pigmented, lesions removal. Picosecond laser is being introduced as the first safe and effective aesthetic laser specifically designed to treat tattoos and pigmented lesions. This innovative laser delivers ultra short pulse bursts of energy to the skin in trillionths of a second. These pulses create a photomechanical effect, that target ink while avoiding unmarked tissue. The pulse shatters the ink into tiny, dust-like particles which are easily eliminated by the body.
V. INDICATIONS FOR USE
The Picosecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery: such as tattoos removal and benign pigmented lesions.
1064nm wavelength:
-
Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, blue, green and purple.
-
Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
-
Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
-
Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
VI. COMPARISON OF TECHNOLOGICAL CHARATERISTICS WITH THE
PREDICATE DEVICE
| Feature | Proposed device | Predicate device(K200116) |
|---|---|---|
| Device Name | Picosecond Nd:YAG LaserSystem | PicoSecond Nd: YAGLaser System |
| Product Code | GEX | GEX |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Device Class | Class II | Class II |
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows an abstract logo design. The logo consists of overlapping geometric shapes, primarily triangles and quadrilaterals. The color palette includes shades of blue and gray, creating a modern and minimalist aesthetic. The arrangement of the shapes suggests a sense of depth and dimension.
巨興醫學科技股份有限公司
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan
TEL : +886 (02) 2298 9578 FAX : +886 (02) 2298 9426
| EDICAL TECHNOLOGY CO.,LTD. TEL : +886 (02) 2298 9578 FAX : +886 (02) 2298 | ||
|---|---|---|
| Indication forUse | The Picosecond Nd:YAG Laser System isintended for use insurgical and aestheticapplication in themedical dermatology andgeneral and plasticsurgery: such as tattoosremoval and benignpigmented lesions.1064nm wavelength:- Removal of tattoos onall skin type (Fitzpatrickskin types I-VI) with thefollowing tattoo colors:black, brown, blue, greenand purple.- Treatment of benignpigmented lesions onFitzpatrick skin types I-IV.532nm wavelength:- Removal of tattoos onFitzpatrick skin types I-III with the followingtattoo colors: red, yellowand orange.- Treatment of benignpigmented lesions onFitzpatrick skin types I-IV. | The PicoSecondNd: YAG LaserSystem is intendedfor use in surgicaland aestheticapplication in themedicaldermatology andgeneral and plasticsurgery as follows:1064nmwavelength:- Removal oftattoos on all skintype (Fitzpatrickskin types I-VI)with the followingtattoo colors:black, brown,green, blue andpurple.- Treatment ofbenign pigmentedlesions onFitzpatrick skintypes I-IV.532nmwavelength:- Removal oftattoos onFitzpatrick skintypes I-III with thefollowing tattoocolors: red, yellowand orange.- Treatment of |
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows an abstract logo with geometric shapes. The logo consists of two overlapping triangular shapes, one in a teal color and the other in a light gray color. The teal triangle is positioned in the lower right corner, while the gray triangle is positioned in the upper left corner, creating a sense of depth and dimension.
巨興醫學科技股份有限公司
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan
TEL:+886 (02) 2298 9578 FAX:+886 (02) 2298 9426
| Feature | Proposed device | Predicate device(K200116) |
|---|---|---|
| benign pigmentedlesions onFitzpatrick skintypes I-IV. | ||
| Laser Type | GaAlAs Diode Laserarray | GaAlAs Diode Laserarray |
| LaserClassification | Class IV | Class IV |
| LaserWavelength | 532 nm and 1064 nm | 532 nm and 1064 nm |
| Laser DeliverySystem | Articulated arm | Articulated arm |
| Laser firingControls | LCD color TouchscreenFootswitch | LCD color TouchscreenFootswitch |
| Pulse energy | 532 nm | 1064 nm |
| 250 mJ | 500 mJ | |
| 532 nm | 1064 nm | |
| 250 mJ | 500 mJ | |
| Frequency | 1, 2, 3, 4, 5, 6, 7, 8, 9, 10Hz (10 adjustable levels) | 1, 2, 3, 4, 5, 6, 7, 8, 9,10 Hz (10 adjustablelevels) |
| Pulse width(Max) | 300~500 ps | 300~500 ps |
| Spot Size | Adjustable spot size 2~10mm | Adjustable spot size 2~10mm |
| Feature | Proposed device | Predicate device(K200116) |
| Cooling | water + air + TEC | water + air + TEC |
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image contains a logo for Smedtrum Medical Technology. The logo features a teal geometric shape on the left, resembling a stylized letter 'S'. To the right of the shape, the text "Smedtrum" is written in a light teal color, with the words "MEDICAL TECHNOLOGY" appearing in smaller, gray font below it. Above the company name, there are some Chinese characters in gray.
VII. PERFORMANCE DATA
The Picosecond Nd:YAG Laser System has been determined through engineering testing to verify laser energy output and electrical safety.
Electrical safety and electromagnetic compatibility
The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2020 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements
IEC 60601-2-22:2019 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern since a failure of the software could result in minor injury to a patient or to a user of the device.
Sterilization and Shelf-Life
The proposed device is not provided sterile and does not need to be sterilized. The handpiece and the body are cleaned with a soft cloth moistened with ethanol of 70% strength or higher. The proposed device is reusable and does not have a restricted shelflife.
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the logo for Smedtrum Medical Technology Co., LTD. The logo features a geometric design on the left, with the company name written in both Chinese and English on the right. The geometric design is made up of overlapping triangles in shades of blue and gray. The text is written in a simple, sans-serif font.
Bench testing
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan TEL:+886 (02) 2298 9578 FAX:+886 (02) 2298 9426
Bench testing was conducted to validate that the laser output energy is within ±20%. Laser energy meter is the instrument for measuring laser energy output which meets IEC 60825. Not only energy but also frequency, pulse width and spot size are consistent with the specification which are under predicate products' specification. Spectrum Analyzer is for wavelength (532 nm/ 1064 nm) checking, Oscilloscope is for frequency and pulse width, then we emitted laser on the photo paper and use ruler to check the size of spots.
VIII. CONCLUSION
The Picosecond Nd: YAG Laser System has the same intended use, similar indications for use, the same technological characteristics, the same energy used, and the same operating principles as its predicates. The non-clinical data and performance testing reports in this submission demonstrate that Picosecond Nd:YAG Laser System meets the expected performance requirements. Any difference between the subject and predicate device do not raise new issues of safety or effectiveness. Based on above analysis, the Picosecond Nd: YAG Laser System is as safe, as effective, and performs as well as the cited predicate device.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.