(95 days)
Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance. Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters.
Omni-Guide Holding, Inc. LISA Laser Surgical Fibers are individually packed sterile devices to provide high quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are for use in laser surgical procedures, including open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing, in soft/hard-tissue application for which compatible surgical lasers are applicable. The key components are the fiber optic, and either an SMA-905, SMA-906, or manufacturer's specific connector. The fibers allow energy to be delivered to the surgical site through the use of glass fiber optic cable. Propagation of the light energy through the glass provides users the ability to direct the energy to the appropriate areas in the body. The Omni Guide Surgical Holding, Inc. single-use LISA Laser Surgical Fibers family of fibers are marketed to physicians as a sterile device within a typical Tyvek/poly pouch. Internally, the fiber is either secured in a wound circle with a Tyvek band, backer-card, or placed in a polyethylene tubing hoop to allow ease of removal. The construction of the fibers is dependent of the application to which it's marketed. There are two main methods of attaching the connector : crimp and adhesive. The crimp offers a reliable connection that will not be affected by heat whereas the epoxy allows a lower cost alternative where high temperatures are not an issue. All fibers offer various connector nuts, heat shrinks, abrasion jackets, strain reliefs or caps that best serve the environment where they are utilized.
The provided document is a 510(k) Premarket Notification for the Omni-Guide LISA Laser Surgical Fibers, determining its substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials and establishing new acceptance criteria based on human performance. Therefore, many of the typical elements of a study proving a device meets acceptance criteria for an AI/CAD system (like sample sizes for test/training sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable to this document.
The document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical performance data, primarily bench testing and adherence to recognized standards.
Here's an analysis based on the provided text, addressing the points where information is available and indicating where it's not applicable:
1. A table of acceptance criteria and the reported device performance:
The document includes a "Substantial Equivalence Comparison Table" which compares the subject device (LISA Laser Surgical Fiber) with the predicate device (Laser Peripherals surgical fiber optic laser delivery devices K170366) across various characteristics and lists non-clinical performance data. Since this is a substantial equivalence submission for a traditional medical device (laser surgical fibers), the "acceptance criteria" are implicitly met by demonstrating equivalence to the predicate and compliance with relevant performance standards through bench testing.
| Acceptance Criteria (Implicitly from Predicate Equivalence & Standards) | Reported Device Performance (Bench Testing & Standards Compliance) |
|---|---|
| Technological Characteristics: | Subject Device Performance: |
| - Product Code: GEX | GEX (Same/Equivalent) |
| - Regulation Number: 21 CFR 878.4810 | 21 CFR 878.4810 (Same) |
| - Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology | Laser surgical instrument for use in general and plastic surgery and in dermatology (Same/Equivalent) |
| - Components: Connector configurations suitable to multiple laser platforms | Connector configurations offered suitable to multiple laser platforms (Same/Equivalent) |
| - Fiber Material: High OH or Low OH silica material w/low attenuation of light wavelengths between 532nm - 2100nm | High OH or Low OH silica material w/low attenuation of light wavelengths between 532nm - 2100nm (Same/Equivalent) |
| - Fiber Numerical Aperture (NA): between 0.22 - 0.48 | Fiber having a Numerical Aperture (NA) between 0.22 - 0.48 (Same/Equivalent) |
| - Fiber Distal Tip: Multiple configurations for suitable performance | Multiple configurations of distal tips offered to provide the most suitable performance for the application (Same/Equivalent) |
| - Core Diameters: Range of sizes suitable to user needs | Core diameters are offered in a range of sizes suitable to user needs (Same/Equivalent) |
| - Connectors: SMA 905, SMA 906, or manufacturer specific | SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors (Same/Equivalent) |
| - Fiber Construction: Core - Fused Silica; Clad – Fused Silica or Fluoropolymer Hard Cladding; Buffer – Fluoropolymer Hard Cladding or Silicone Acrylate; Jacket - Nylon, Polyimide, or Teflon | Core - Fused Silica; Clad – Fused Silica or Fluoropolymer Hard Cladding; Buffer – Fluoropolymer Hard Cladding or Silicone Acrylate; Jacket - Nylon, Polyimide, or Teflon (Same/Equivalent) |
| - Peak and Continuous Wavelengths: 500nm-2200nm | 500nm-2200nm (Same/Equivalent) |
| - Power Ranges: 1-300 Watts | 1-300 Watts (Same/Equivalent) |
| - Compatibility with surgical laser systems | Fibers are compatible with any cleared laser system with an appropriate connection system (Same/Equivalent) |
| - Sterilization Method: EtO | EtO (Same/Equivalent) |
| Non-Clinical Performance: | Bench testing on the subject device has shown the device to perform as intended with the same technological principle, fit, form, function and method of operating, as the single use fibers of K170366. Tested for conformance to various performance standards (ISO 11135-1, ISO 11607-1, ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, ISO 14971, ASTM D4169, ASTM F88-09, ASTM F2096-11, ASTM F1980-07, ISO 14644-1, AAMI TIR12, ISO 17664, ISTA Project 2A, ASTM F56-13, ASTM F619-14). Specific performance tests included: Power & Energy input versus output, Homogeneity of output light (spot check, beam profile), High-power testing, Bend radius testing, Pull testing, Feature specific testing (e.g., Nav Tip traversing deflected endoscope), Scatter Free Fiber, Expanded transmission of laser wavelength/energy, and LaseGuide Nav distal tip configuration. These tests indicate passed testing of specific features or overall products, proving safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This submission is for a traditional medical device, relying on bench testing and adherence to standards, not a diagnostic AI/CAD system that would typically have a "test set" of clinical data. The non-clinical performance data section describes "bench testing" without specifying sample sizes in this summary. The data provenance is laboratory-based testing conducted by the manufacturer, Omni-Guide Holdings, Inc.
3. 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 Applicable. Ground truth in the context of clinical expert review or diagnostic accuracy is not relevant for this device's submission type. Testing focused on engineering and material performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for clinical studies involving human interpretation or diagnostic agreement, which is not the case here.
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 is not an AI/CAD device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The device is a laser surgical fiber, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Indirect. The "ground truth" for this type of device is implicitly defined by the safety and performance requirements of the predicate device and the relevant international and national standards (e.g., ISO, ASTM) that the device must meet through bench testing. For example, a successful bond strength test (per ASTM F88-09) or successful sterilization (per ISO 11135-1) serves as the "truth" that the device performs as intended in that particular aspect.
8. The sample size for the training set:
- Not Applicable. This refers to machine learning algorithms, which are not involved here.
9. How the ground truth for the training set was established:
- Not Applicable. This refers to machine learning algorithms, which are not involved here.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
April 29, 2022
Omni-Guide Holdings, Inc. Carlos Acosta Global Director Regulatory Affairs & Quality Assurance 46 Manning Road Billerica, Massachusetts 01821
Re: K220189
Trade/Device Name: LISA Laser Surgical Fibers 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: January 12, 2022 Received: January 24, 2022
Dear Carlos Acosta:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/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.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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). 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-device-advice-comprehensive-regulatoryassistance/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.
Purva Pandya, D.Eng. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220189
Device Name Omni-Guide LISA Laser Surgical Fibers
Indications for Use (Describe)
Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500mm have received regulatory clearance. Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters.
| 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) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| X Prescription Use (Part 21 CFR 801 Subpart D) | ||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 008_510(k)_Summary | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | -------------------- |
| Classification Name | Common Name | Trade Name/Proprietary Name |
|---|---|---|
| Part 878 General and Plastic Surgery 21 CFR§874.4680 | LISA Laser Surgical Fibers | Surgical Fibers |
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of Omni Guide knowledge.
| Submitter: | Omni-Guide Holdings, Inc.46 Manning DriveBillerica, MA 01821 |
|---|---|
| Contact: | Carlos O. AcostaPhone: 617-551-4400 Ext. 563Fax: 888-490-6020 |
| 510(k) Co-Author | Irina FedorovPhone: 617-551-4400 Ext.Fax: 888-490-6020 |
| Date ofPreparation: | December 16, 2021 |
| Type of 510(k)Submission: | Traditional |
| DeviceIdentification: | Trade Name: LISA Laser Surgical FibersClassification Name: Laser surgical instrument for use in general and plastic surgery and indermatology |
| RegulatoryClass: | II |
| Product Code: | GEX |
| PanelClassification | General and Plastic Surgery (21 CFR §878.4810) |
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K220189
| Predicate Device: | Primary Predicate Device:Laser Peripherals' Family of Surgical Fiber Optic Laser DeliveryDevice 510(k) = K170366 | |||
|---|---|---|---|---|
| DeviceDescription: | Omni-Guide Holding, Inc. LISA Laser Surgical Fibers are individually packed sterile devices to provide highquality surgical laser fiber optic delivery systems for laser surgery. The Fibers are for use in laser surgicalprocedures, including open, laparoscopic, or endoscopic ablation, coagulation, incision, and excisionor vaporizing, in soft/hard-tissue application for which compatible surgical lasers are applicable. The keycomponents are the fiber optic, and either an SMA-905, SMA-906, or manufacturer's specificconnector. The fibers allow energy to be delivered to the surgical site through the use of glass fiber optic cable.Propagation of the light energy through the glass provides users the ability to direct the energy to the appropriateareas in the body.The Omni Guide Surgical Holding, Inc. single-use LISA Laser Surgical Fibers family of fibers are marketed tophysicians as a sterile device within a typical Tyvek/poly pouch. Internally, the fiber is either secured in a woundcircle with a Tyvek band, backer-card, or placed in a polyethylene tubing hoop to allow ease of removal. Theconstruction of the fibers is dependent of the application to which it's marketed. There are two mainmethods of attaching the connector : crimp and adhesive. The crimp offers a reliable connection that will notbe affected by heat whereas the epoxy allows a lower cost alternative where high temperatures are not anissue. All fibers offer various connector nuts, heat shrinks, abrasion jackets, strain reliefs or caps that best servethe environment where they are utilized. | |||
| Indications ForUse: | Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers are indicated for use in all surgicalspecialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm havereceived regulatory clearance. Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers devices areintended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, ormanufacturer specific connectors and adapters. | |||
| SubstantialEquivalenceComparisonTable | Characteristic | Subject DeviceLISA Laser Surgical Fiber | Primary Predicate, LaserPeripherals surgical fiberoptic laser delivery devicesK170366 | Equivalence |
| 510(k) Number | Pending | K170366 | N/A | |
| Product Code | GEX | GEX | Same/Equivalent | |
| RegulationNumber | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | |
| RegulationName | Laser surgical instrument foruse in general and plasticsurgery and in dermatology | Laser surgical instrument foruse in general and plasticsurgery and in dermatology | Same/equivalent | |
| Components | Connector configurationsoffered suitable tomultiple laser platforms | Connector configurationsoffered suitable tomultiple laser platforms | Same/Equivalent | |
| Technologicalcharacteristics | High OH or Low OH silicamaterial w/low attenuation oflight wavelengths between532nm - 2100nm | High OH or Low OH silicamaterial w/low attenuation oflight wavelengths between532nm - 2100nm | Same/Equivalent | |
| Silica/Silicafibers/hard cladfibers | Fiber having a NumericalAperture (NA) between0.22 - 0.48 | Fiber having a NumericalAperture (NA) between 0.22- 0.48 | Same/Equivalent | |
| Fiber distal tip | Multiple configurations ofdistal tips offered to providethe most suitable performancefor the application | Multiple configurations ofdistal tips offered to providethe most suitable performancefor the application | Same/Equivalent | |
| Used withattachments | Core diameters are offeredin a range of sizes suitable touser needs | Core diameters are offeredin a range of sizes suitable touser needs | Same/Equivalent | |
| Connectors | SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors | SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors | Same/Equivalent | |
| FiberConstruction | Core - Fused SilicaClad – Fused Silica or Fluoropolymer Hard CladdingBuffer – Fluoropolymer Hard Cladding or Silicone AcrylateJacket - Nylon, Polyimide, or Teflon | Core - Fused SilicaClad – Fused Silica or Fluoropolymer Hard CladdingBuffer – Fluoropolymer Hard Cladding or Silicone AcrylateJacket - Nylon, Polyimide, or Teflon | Same/Equivalent | |
| FiberNumericalAperture | Fiber having a numericalAperture (NA) between 0.22-048 | Fiber having a NumericalAperture (NA) between 0.22-048 | Same/Equivalent | |
| Peak andContinuousWavelengths | 500nm-2200nm | 500nm-2200nm | Same/Equivalent | |
| Power Ranges | 1-300 Watts | 1-300 Watts | Same/Equivalent | |
| Diameter | Core diameters areoffered in a range of sizessuitable to user needs | Core diameters areoffered in a range of sizessuitable to user needs | Same/Equivalent | |
| Fiber DistalTip | Multiple configurations ofdistal tips offered to providethe most suitable performancefor the application | Multiple configurations ofdistal tips offered to providethe most suitable performancefor the application | Same/Equivalent | |
| Compatibilitywith surgicallaser systems | Fibers are compatiblewith any cleared lasersystem with anappropriate connectionsystem | Fibers are compatiblewith any cleared lasersystem with anappropriate connectionsystem | Same/Equivalent | |
| Sterilization | EtO | EtO | Same/Equivalent | |
| Non-ClinicalPerformanceData: | Bench testing on the subject device has shown the device to perform as intended with the same technologicalprinciple, fit, form, function and method of operating, as the single use fibers of K170366. Fibers includedin this premarket notification were tested for conformance to the following performance standards: | |||
| Document Number | Title | |||
| ISO 11135-1 | Sterilization of Health Care Products - EthyleneOxide - Requirements for the development, validation and routinecontrol sterilization process for medical devices | |||
| ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1:Requirements for materials, sterile barrier systems and packagingsystems | |||
| ISO 10993-1 | Biological Evaluation of Medical Devices - Part 1:Evaluation and testing | |||
| ISO 10993-5 | Biological Evaluation of Medical Devices - Part 5:Tests for in vitro cytotoxicity | |||
| ISO 10993-7 | Biological Evaluation of Medical Devices - Part 7:Tests for Ethylene Oxide Sterilization Residuals | |||
| ISO 10993-10 | Biological Evaluation of Medical Devices - Part 5:Tests for Irritation and Skin Sensitization | |||
| ISO 10993-11 | Biological Evaluation of Medical Devices - Part 5: Tests for SystemicToxicity | |||
| ISO 14971 | Medical devices - Application of Risk Managementto Medical Devices | |||
| ASTM D4169 | Standard Practice for Performance Testing ofShipping Containers and Systems | |||
| ASTM F88-09 | Standard Test Method for Seal Strength of FlexibleBarrier Materials | |||
| ASTM F2096-11 | Standard Test Method for Detecting Gross Leaks inPackaging by Internal Pressurization (Bubble Test) | |||
| ASTM F1980-07 | Standard Guide for Accelerated Aging of SterileBarrier Systems for Medical Devices | |||
| ISO 14644-1 | Cleanrooms and associated controlled environments- Part 1: Classification of air cleanliness by particle concentration | |||
| AAMI TIR12 | Designing, Testing, and Labeling Reusable Medical Devices forReprocessing in Health Care Facilities | |||
| ISO 17664 | Sterilization of medical devices—Information to be provided by themanufacturer for the processing of sterilizable medical devices | |||
| ISTA Project 2A | Series, Partial-Simulation Performance Test | |||
| ASTM F56-13 | Standard Practice for Assessment of Hemolytic Propertiesof Materials, 2013 | |||
| ASTM F619-14 | Standard Practice for Extraction of Medical Plastics | |||
| The performance test reports focus on the key features of the fiber. These included the following testing(depending on need):Power & Energy input versus output | ||||
| Homogeneity of output light (spot check, beam profile)High-power testingBend radius testing | ||||
| Pull testingFeature specific testing (i.e. Nav Tip tested for ability to traverse deflected endoscope)Much of the testing performed was based on a specific (usually new) feature approach. Those featuresindicated in the attachments are 1) Scatter Free Fiber, 2) Expanded transmission of laser wavelength/energy,and 3) LaseGuide Nav distal tip configuration. These test reports show the features identified are proven tobe safe and effective. Other reports are similar in that they indicate passed testing of specific features oroverall products | ||||
| AnimalTesting | Animal testing is not needed to support the safety and efficacy of the single use fibers that are subject of thispremarket notification. | |||
| ClinicalPerformance | Clinical testing is not needed to support the safety and efficacy of the single use fibers that are subject of thispremarket notification. |
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K220189
Page 3 of 5
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| Conclusion: | The single-use optical fibers that are the subject of this premarket notification use identical or similar technology as that of the single-use fibers of the K170366 510(k). Testing of key performance characteristics demonstrates that the single-use optical fibers that are the subject of this premarket notification can be used safely and effectively for the proposed indications for use. The Omni Guide single-use Surgical Holding, Inc. LISA Laser Surgical Fibers are considered to be substantially equivalent to the single-use fibers of the predicate K170366. |
|---|---|
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
§ 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.