(28 days)
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No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the laser technology and its intended uses.
Yes
The device is used for incision, excision, ablation, and vaporization of human soft tissue, which are therapeutic interventions.
No
The device, a Fractional C02 Laser System, is indicated for therapeutic uses such as incision, excision, ablation, vaporization, and ablative skin resurfacing. It does not mention any function related to diagnosing a condition or disease.
No
The device description explicitly states "SMAXEL CO2 Surgical Laser System," indicating a hardware component (a laser system) is involved, not just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- SMAXEL Function: The SMAXEL Fractional CO2 Laser System is a surgical laser used for direct treatment of human soft tissue through incision, excision, ablation, and vaporization. It operates on the body, not on samples taken from the body.
- Intended Use: The intended use clearly describes surgical procedures performed directly on the patient.
Therefore, based on the provided information, the SMAXEL is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SMAXEL (formally the MX-7000 MICROXEL) Fractional C02 Laser System is indicated for use in non-fractional mode is incision, excision, ablation, vaporization of human soft tissue. Intended for use in Dermatology, Plastic and General Surgery, Gynecology, Neurosurgery, and Podiatry.
When used in fractional mode, the SMAXEL Fractional C02 Laser System indications for use in ablative skin resurfacing, wrinkles, fine lines, rhylides, and furrows in Dermatology, Plastic and General Surgerv,
Product codes
ONG, GEX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.
February 2, 2018
Ids. Ltd. % Alexander Henderson Official Correspondent BraunSolutions 970 South Dawson Way, Unit 14 Aurora, Colorado 80012
Re: K180036
Trade/Device Name: SMAXEL CO2 Surgical 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: ONG, GEX Dated: January 2, 2018 Received: January 5, 2018
Dear Alexander Henderson:
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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -53 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180036
Device Name
SMAXEL Fractional CO2 Laser System (formally MX-7000 MICROXEL)
Indications for Use (Describe)
The SMAXEL (formally the MX-7000 MICROXEL) Fractional C02 Laser System is indicated for use in non-fractional mode is incision, excision, ablation, vaporization of human soft tissue. Intended for use in Dermatology, Plastic and General Surgery, Gynecology, Neurosurgery, and Podiatry.
When used in fractional mode, the SMAXEL Fractional C02 Laser System indications for use in ablative skin resurfacing, wrinkles, fine lines, rhylides, and furrows in Dermatology, Plastic and General Surgerv,
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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