(89 days)
The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as long term, stable reduction in the number of hairs re-growing when measured at 6,9, and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI) including tanned skin.
The Bare : 808 Laser is a microprocessor-controlled, user friendly, sealed diode laser system that produces a wavelength of 808nm with a maximum energy of 120Jcm2. The system incorporates a diode laser within each hand piece, and the energy is delivered from the hand piece directly to the desired target. The Bare: 808 Laser consists of a console, a touch screen user interface, a footswitch and 1 handpiece.
This document is a 510(k) Summary for the Bare: 808 Laser System (K193446), a device intended for permanent hair reduction.
Here's an analysis of the provided text regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that a human clinical study was not required because the device is considered substantially equivalent to predicate devices. Therefore, there is no direct table of acceptance criteria for diagnostic/performance metrics (e.g., sensitivity, specificity) derived from a clinical study for the Bare: 808 device itself.
Instead, the "Performance Data" section lists compliance with relevant IEC (International Electrotechnical Commission) standards for electrical safety and electromagnetic compatibility as the acceptance criteria for these aspects. The reported performance is that the device was tested and complied with these standards.
| Acceptance Criteria (Performance Data) | Reported Device Performance |
|---|---|
| IEC 60601-1:2005 (Third Edition) + CORR.1:2006 + CORR.2:2007 + A1:2012 (or IEC 60601-1:2012 reprint): Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance. | Complied |
| IEC 60601-1-2:2014, EN 60601-1-2:2015 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility | Complied |
| IEC 60601-2-22:2007 + A1:2012: Test for Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | Complied |
For its intended use and indications for use, the acceptance criterion implicitly is substantial equivalence to the predicate device (Soprano Ice K140009), meaning it performs as safely and effectively. The document provides a comparison table of technical specifications between the Bare: 808 and the predicate device to demonstrate this equivalence, rather than a direct performance metric.
| Characteristic | Bare : 808 (K193446) | Soprano Ice (K140009)** | Conclusion of Equivalence |
|---|---|---|---|
| Intended Use | Same as predicate | Substantially equivalent | |
| Indication for Use | Same as predicate | Substantially equivalent | |
| Wavelength (nm) | 808 | 810 | Similar |
| Laser Media | Solid State | Solid State | Similar |
| Modes | HRS, HRM | HR, SHR | Similar |
| Energy Density (Fluence) | 2-120 (HRS), 2-20 (HRM) | 2-120 (HR), 2-20 (SHR) | Similar |
| Spot Size (mm) | 14 x 14 | 12 x 10, 20 x 10 | Similar |
| Pulse Width (msec) | 15-400 (HRS), 15-266 (HRM) | 5-200 | Similar |
| Repetition Rate (Hz) | 3-10 | 3-10 | Similar |
| Delivery Devices | Nonsterile, Reusable, cleanable | Nonsterile, Reusable, cleanable | Similar |
2. Sample size used for the test set and the data provenance:
- No clinical test set was used for the K193446 submission. The document states: "A human clinical study was not required as the device is substantially equivalent to the predicate devices."
- Data provenance for a clinical test set is therefore not applicable to this submission. The performance data provided is related to engineering and safety standards compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set was required or used.
4. Adjudication method for the test set:
- Not applicable, as no clinical test set was required or used.
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:
- No MRMC study was done, as this device is a laser system for hair removal, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this device is a laser system, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this submission primarily relies on compliance with established international safety and performance standards (IEC) for medical electrical equipment and laser devices, as well as the technical specifications and intended use of a legally marketed predicate device to establish substantial equivalence.
8. The sample size for the training set:
- Not applicable, as this is a hardware laser device, not a machine learning algorithm that requires a training set in the typical sense. Any internal development or testing would relate to engineering validation, not an AI training set.
9. How the ground truth for the training set was established:
- Not applicable, as it's not an AI/ML device requiring a training set with established ground truth.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
LUVO Medical Technologies, Inc Mr. Gregory Berzak Regulatory Affairs Officer 125 Fleming Dr. Cambridge. CA N1T 288 Ontario
March 10, 2020
Re: K193446
Trade/Device Name: Bare: 808 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: December 6, 2019 Received: December 12, 2019
Dear Gregory Berzak:
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.
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
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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 medical devices and radiation-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,
Neil R.P. Ogden, MS Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193446
Device Name Bare: D808 Laser System
Indications for Use (Describe)
The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as long term, stable reduction in the number of hairs re-growing when measured at 6,9, and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI) including tanned skin
| 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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Attachment 5 510(K) Summary Bare : 808 Laser System (K193446)
This 510(K) Summary of safety and effectiveness for the Bare : 808 Laser System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | LUVO Medical Technologies, Inc. |
|---|---|
| Address: | LUVO Medical Technologies, Inc.125 Fleming DrCambridge, Ontario, Canada N1T 2B8 |
| Contact Person: | Mr. Gregory Berzak |
| Telephone: | 519-6203900- phonegregoryb@clarionmedical.com |
| Preparation Date: | December 6, 2019 |
| Device Trade Name: | Bare : 808 |
| Common Name: | Powered laser surgical instrument |
| Regulation Name: | Laser surgical instrument for use in general andplastic surgery and dermatology |
| Regulation Number: | 21 CFR 878.4810 (Product Code: GEX) |
| Legally Marketed Predicate Devices: | Soprano XL Family of Multi-application and Multi-technologyPlatform |
| 510(K) number: | (K)140009(K)170626 (Reference Only) |
| Regulatory Class: | Class II Prescription Use |
| Description of the Bare : 808 LaserSystem: | The Bare : 808 Laser is a microprocessor-controlled, userfriendly, sealed diode laser system that produces awavelength of 808nm with a maximum energy of 120Jcm2.The system incorporates a diode laser within each handpiece, and the energy is delivered from the hand piecedirectly to the desired target. The Bare: 808 Laser consistsof a console, a touch screen user interface, a footswitch and1 handpiece. |
| Intended use / Indication for use ofBare : 808 Laser System | The hair removal single (HRS) and hair removal moving(HRM) modes are intended for permanent reduction in hairregrowth defined as long term, stable reduction in thenumber of hairs re-growing when measured at 6,9, and 12months after the completion of a treatment regimen.Use on all skin types (Fitzpatrick I-VI) including tanned skin. |
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| Performance Data: | The following performance data was provided in support of the substantial equivalence determination: |
|---|---|
| IEC 60601-1:2005 (Third Edition) + CORR.1:2006 + CORR.2:2007 + A1:2012 (or IEC 60601-1:2012 reprint): Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance. | |
| IEC 60601-1-2:2014, EN 60601-1-2:2015 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility | |
| IEC 60601-2-22:2007 + A1:2012: Test for Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | |
| Results of Clinical Study: | A human clinical study was not required as the device is substantially equivalent to the predicate devices. |
Technical Specifications / Indications
for Use Comparison:
| Bare: D808 (K193446) | Soprano Ice (K140009) | |
|---|---|---|
| Intended Use | The device is intended for use indermatologic and general surgicalprocedures | The device is intended for use indermatologic and general surgicalprocedures |
| Indication forUse | The hair removal single (HRS)and hair removal moving (HRM)modes are intended forpermanent reduction in hairregrowth defined as long term,stable reduction in the number ofhairs re-growing when measuredat 6,9, and 12 months after thecompletion of a treatmentregimen.Use on all skin types (FitzpatrickI-VI) including tanned skin. | The hair removal (HR) and superhair removal (SHR) mode areintended for permanent reduction inhair regrowth defined as long term,stable reduction in the number ofhairs re-growing when measured at6,9, and 12 months after thecompletion of a treatment regimen.Use on all skin types (Fitzpatrick I-VI) including tanned skin. |
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Attachment 5 510(K) Summary Bare : 808 Laser System (K193446)
| Characteristic | Bare : 808 (K193446) | Soprano Ice (K140009)** | ||
|---|---|---|---|---|
| Wavelength (nm) | 808 | 810 | ||
| Laser Media | Solid State | Solid State | ||
| Modes | HRS | HRM | HR | SHR |
| Energy Density (Fluence) | 2-120 | 2-20 | 2-120 | 2-20 |
| Spot Size (mm) | 14 x 14 | 14 x 14 | 12 x 10 | 20 x 10 |
| Pulse Width (msec) | 15-400 | 15-266 | 5-200 | 5-200 |
| Repetition Rate (Hz) | 3-10 | 3-10 | ||
| Delivery Devices | Nonsterile, Reusable, cleanable | Nonsterile, Reusable, cleanable |
** The Soprano Ice (K140009) has additional wavelengths and specifications that have not been included as part of this submission. The comparison of the Bare: 808 and the Soprano Ice are for the diode hair removal module only.
The Bare : 808's intended use, indications for use and technical specifications Conclusion: are substantially equivalent to the 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.