(89 days)
No
The device description mentions a "microprocessor-controlled" system, which is standard for many medical devices and does not inherently indicate AI/ML. There are no mentions of AI, DNN, ML, or image processing, nor are there descriptions of training or test sets typically associated with AI/ML development. The performance studies focus on electrical and laser safety standards, not AI/ML performance metrics.
Yes
The device is described as "surgical, cosmetic, therapeutic and diagnostic laser equipment" in the performance studies section, indicating its therapeutic intent.
No
The device is described as a hair removal laser system with an intended use for permanent reduction in hair regrowth. This description indicates a therapeutic purpose rather than a diagnostic one.
No
The device description clearly states it is a "sealed diode laser system" consisting of a console, touch screen, footswitch, and handpiece, indicating it is a hardware device with embedded software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "permanent reduction in hair regrowth." This is a therapeutic/cosmetic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a laser system that delivers energy to the skin. This is consistent with a therapeutic device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), image processing for diagnostic purposes, or any other activities typically associated with IVDs.
The device is clearly intended for a physical treatment (hair removal) and not for diagnosing a condition or providing information about a patient's health status through the analysis of biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Study Type: Performance Data (Compliance with IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-22:2007).
Sample Size: Not applicable.
AUC: Not applicable.
MRMC: Not applicable.
Standalone Performance: Not applicable.
Key Results: The device was found to be in compliance with the specified IEC standards for basic safety, essential performance, electromagnetic compatibility, and particular requirements for surgical, cosmetic, therapeutic, and diagnostic laser equipment.
Clinical Study: A human clinical study was not required as the device is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 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
1
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 Dr | |
| Cambridge, Ontario, Canada N1T 2B8 | |
| Contact Person: | Mr. Gregory Berzak |
| Telephone: | 519-6203900- phone |
| gregoryb@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 and |
| plastic surgery and dermatology | |
| Regulation Number: | 21 CFR 878.4810 (Product Code: GEX) |
| Legally Marketed Predicate Devices: | Soprano XL Family of Multi-application and Multi-technology |
| Platform | |
| 510(K) number: | (K)140009 |
| (K)170626 (Reference Only) | |
| Regulatory Class: | Class II Prescription Use |
| Description of the Bare : 808 Laser | |
| System: | 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. | |
| Intended use / Indication for use of | |
| Bare : 808 Laser System | The hair removal single (HRS) and hair removal moving |
| (HRM) modes 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. |
4
| 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 in | |
| dermatologic and general surgical | ||
| procedures | The device is intended for use in | |
| dermatologic and general surgical | ||
| procedures | ||
| Indication for | ||
| Use | The hair removal single (HRS) | |
| and hair removal moving (HRM) | ||
| modes 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 hair removal (HR) and super
hair removal (SHR) 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. |
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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.