(92 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The "Smart" in the model name is not sufficient evidence of AI/ML.
No.
The device is used for cosmetic hair reduction, which is not a therapeutic medical condition.
No.
Explanation: The "Intended Use / Indications for Use" section states that the device is intended for the "removal, permanent reduction of hair," which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states it is "micro-controlled equipment used in diode laser therapies," indicating it is a hardware device that emits laser light.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal and permanent reduction of hair on the skin. This is a therapeutic/cosmetic procedure performed directly on the patient's body.
- Device Description: The device is a diode laser used for hair removal. It applies energy to the skin.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatments. This device does not perform any such analysis of biological specimens.
The device is a medical device, but it falls under a different category than IVDs. It's a therapeutic laser device.
N/A
Intended Use / Indications for Use
The Dermatological Diode Laser (Model: Hakon Smart) are intended for the removal, permanent reduction of hair on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Permanent hair reduction is defined as the stable, longterm reduction in the number of hairs growing back when measured at 6, 9, and 12 months after completion of a treatment regimen.
Product codes
GEX
Device Description
The Hakon and Hakon Smart device is a micro-controlled equipment used in diode laser therapies at wavelengths of 808nm intended to remove unwanted hair.
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, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Evaluation (Performance and Safety Evaluation): The device Hakon and Hakon Smart was developed, as well produced in compliance with recognized international regulations and standards for the medical device industry.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 of 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 28, 2023
Medical San Indústria de Equipamentos Médicos Ltda % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 2950 West Cypress Creek Rd. Ste 110 Fort Lauderdale, Florida 33309
Re: K231901
Trade/Device Name: Hakon, Hakon Smart 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: June 27, 2023 Received: June 28, 2023
Dear Rodrigo Abreu:
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 (the 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/cdrh/ofdocs/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.
2
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,
Tanisha L. Hithe -S Tanisha L. Hithe -S 2023.09.28 17:04:54 -04'00'
Tanisha Hithe, MS, MHS Assistant Director 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
3
Indications for Use
510(k) Number (if known) K231901
Device Name Hakon and Hakon Smart
Indications for Use (Describe)
The Dermatological Diode Laser (Model: Hakon Smart) are intended for the removal, permanent reduction of hair on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Permanent hair reduction is defined as the stable, longterm reduction in the number of hairs growing back when measured at 6, 9, and 12 months after completion of a treatment regimen.
| 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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Image /page/4/Picture/0 description: The image contains the logo for Medical San. The logo consists of a circular emblem with intertwined letters, possibly "SS", in a blue color scheme. Below the emblem, the words "MEDICAL SAN" are written in a bold, sans-serif font, with "MEDICAL" stacked above "SAN".
Medical San Indústria de Equipamentos Médicos Ltda. Rua Alberto Muller, 1100 Block 20 - Rooms 404 and 406 Bairro Carneiros - Lajeado RS - Brazil - 95913-528
Section 5 K231901 510(k) SUMMARY
A) Submitter's Name: Medical San Indústria de Equipamentos Médicos Ltda.
Owner / Operator Registration Number: Not available yet.
Manufacturer Registration Number: Not available yet.
Address: Rua Alberto Muller, 1100 Block 20 - Rooms 404 and 406
Bairro Carneiros - Lajeado RS - Brazil - 95913-528
B) Phone and Fax Numbers
Tel .: +55 (51) 3720-2762
Fax: +55 (51) 3720-2762
C) Contact Person:
Francis Laion de Padua Tel.: +55 (51) 3720-2762 Email: requlatorio@medicalsan.com.br
D) Preparation Date: September 27, 2023
E) Classification Name:
Common / Usual Name: Powered laser surqical instrument
Proprietary Name: Hakon and Hakon Smart
Product Code: GEX
Class: Class II
Regulation: 21 CFR 878.4810
F) Device Description
The Hakon and Hakon Smart device is a micro-controlled equipment used in diode laser therapies at wavelengths of 808nm intended to remove unwanted hair.
G) Device Operations Principles
The technique is based on the principle of selective thermal destruction, specifically targeting the germinal cells within the hair follicle. By utilizing laser light, the melanin present in the hair absorbs the energy, leading to the destruction of the hair bulbs in the anagen phase represents the active growth stage of the hair follicle, characterized by highly pigmented matrix cells and a connection to the dermal papilla. It is during this phase that the treatment achieves its highest success rates.
Melanin, being the primary chromophore in hair follicles, enables the utilization of light wavelengths ranging from 600 to 1100nm for safe and effective photo thermolysis. These wavelengths ensure optimal targeting of the hair follicles while maintaining efficacy and safety throughout the treatment process.
H) Predicate Device:
The Hakon and Hakon Smart is equivalent with the following predicate device:
| 510(k) Number | Model | Company |
|---|---|---|
| K210663 | CM01D/CM02D | Beijing HuaCheng Taike |
| Technology Co., Ltd. |
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Image /page/5/Picture/0 description: The image shows the logo for Medical San. The logo consists of a blue circle with a white design inside, and the words "MEDICAL SAN" in black, bold letters below. The design inside the circle appears to be two intertwined letters, possibly "S" or "B". The logo is simple and professional, and the use of blue and black gives it a sense of trustworthiness and authority.
Medical San Indústria de Equipamentos Médicos Ltda. Rua Alberto Muller, 1100 Block 20 - Rooms 404 and 406
Bairro Carneiros – Lajeado RS – Brazil - 95913-528
I) Substantial Equivalence Comparison
Indications for Use: a.
| Indications for Use Comparison | |
|---|---|
| Hakon and Hakon Smart | CM01D/CM02D |
| The Dermatological Diode Laser (Model: Hakon and Hakon | |
| Smart) is intended for the removal, permanent reduction of | |
| hair on all skin types (Fitzpatrick skin types I-VI), including | |
| tanned skin. Permanent hair reduction is defined as the | |
| stable, long-term reduction in the number of hairs growing | |
| back when measured at 6, 9, and 12 months after | |
| completion of a treatment regimen. | The Dermatological Diode Laser (Model: CM01D/ CM02D) is |
| intended for the removal, permanent reduction of hair on all | |
| skin types (Fitzpatrick skin types I-VI), including tanned skin. | |
| Permanent hair reduction is defined as the stable, long-term | |
| reduction in the number of hairs growing back when | |
| measured at 6, 9, and 12 months after completion of a | |
| treatment regimen. |
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Image /page/6/Picture/0 description: The image contains the logo for Medical San. The logo consists of a blue circle with the letters "SS" inside, stacked on top of each other. Below the logo, the words "MEDICAL SAN" are written in bold, black letters. The word "SAN" has a trademark symbol next to it.
Technological Characteristics Comparison: b.
The predicate devices used to establish substantial equivalence for the Hakon Smart device is outlined below. This section of this submission will provide a comparison of design, materials, and technical specifications of the Hakon and Hakon Smart to each of the predicate devices stratified by functional modality.
| ITEM | PROPOSED DEVICE | PREDICATE DEVICE K210663 | OBSERVATION |
|---|---|---|---|
| Device Name | Equipment Laser System for Depilation | Diode laser dermatology systems | - |
| Product Model | Hakon and Hakon Smart | CM01D/CM02D | - |
| K number | K210663 | - | |
| Product code | GEX | GEX | Same |
| Regulation classification | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Class | 2 | 2 | Same |
| Indication of Use | The Dermatological Diode Laser (Model: | ||
| Hakon and Hakon Smart) is intended for the | |||
| removal, permanent reduction of hair on all | |||
| skin types (Fitzpatrick skin types I-VI), | |||
| including tanned skin. Permanent hair | |||
| reduction is defined as the stable, long-term | |||
| reduction in the number of hairs growing | |||
| back when measured at 6, 9, and 12 months | |||
| after completion of a treatment regimen. | The Dermatological Diode Laser (Model: CM01D/ | ||
| CM02D) is intended for the removal, permanent | |||
| reduction of hair on all skin types (Fitzpatrick skin | |||
| types I-VI), including tanned skin. Permanent hair | |||
| reduction is defined as the stable, long-term | |||
| reduction in the number of hairs growing back | |||
| when measured at 6, 9, and 12 months after | |||
| completion of a treatment regimen. | Same | ||
| Settings | Main Unit | Main Unit | Same |
| hand piece | hand piece | Same | |
| control pedal | control pedal | Same | |
| principle of operation | diode laser | diode laser | Same |
| Laser Type | diode laser | diode laser | Same |
| laser rating | Class IV | Class IV | Same |
| Wave-length | 808nm | 808nm | Same |
| Spot size | 10x12mm | CM01D: 10 x 30 mm | Similar |
| CM02D: 9x12mm | |||
| Fluency | 1-70 J/cm2 | CM01D: 5-100 J/cm² | Similar |
| CM02D: 3-30 J/cm² | |||
| Frequency | 1-10 Hz | CM01D: 1-10 Hz | Same |
| CM02D: 1-3 Hz | |||
| Pulse Duration | 10 -400 ms | CM01D: 15-400ms | Similar |
| CM02D: 35-400ms | |||
| Power supply | 110V/60Hz or 230V/50Hz | AC 110V/60Hz | Similar |
| Dimension | 393 mm x 430 mm x 1130 mm | CM01D: 650 mm x 650 mm x 1230 mm | Similar |
| CM02D: 252 mm x 210 mm x 193 mm | |||
| Weight | 65kg | 60kg | Similar |
| EMC, electrical and laser safety | |||
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| Laser Safety | Comply with IEC 60601-2-22 | Comply with IEC 60601-2-22 | Same |
| Direct/indirect patient contact materials and biocompatibility | |||
| Patient | |||
| direct indirect | Tip of the Handle (6063 Aluminum & Quartz) | Tip of the Handle (6063 Aluminum & Quartz) | Same |
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Image /page/7/Picture/0 description: The image contains the logo for Medical San. The logo consists of a circular emblem with intertwined letters inside, positioned above the words "MEDICAL SAN" in bold, sans-serif font. The emblem and text are in a dark color, possibly blue or black, against a white background.
Medical San Indústria de Equipamentos Médicos Ltda.
Rua Alberto Muller, 1100 Block 20 - Rooms 404 and 406 Bairro Carneiros – Lajeado RS – Brazil - 95913-528
8
Image /page/8/Picture/0 description: The image shows the logo for Medical San. The logo consists of a blue circle with the letters "SS" inside, stacked on top of each other. Below the circle is the text "MEDICAL SAN" in a bold, sans-serif font, with "SAN" having a trademark symbol next to it.
| Contact | |||
|---|---|---|---|
| Materials | |||
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same |
SE Discussion
The subject device differs from the predicate in several key aspects, including spot size, fluency range, and pulse duration.
Spot Size: The predicate device has a spot size ranging from a minimum of 9mm to a maximum of 30mm, while the subject device falls within the
dimensions of 10mm to 12mm. This ensures that the subject device maintains a safe spot size within the range specified by the predicate.
Fluency Range: The predicate device has a fluency range of 3 - 100J/cm², whereas the subject device has a lower fluency range of 1 - 70J/cm².
The subject device has a maximum thermal energy 30% lower than the predicate and a minimum thermal energy 76% lower.
Pulse Duration: The predicate device has a pulse duration limit of 15 - 400ms, while the subject device has a pulse duration of 10 - 400ms. The
subject device's pulse duration has a minimum limit that is 30% lower than that of the predicate. Since the subject device has a lower pulse
duration limit and not a higher one, it ensures safety in terms of pulse duration characteristics.
These differences highlight that the subject device is designed with specific technical specifications that prioritize safety. The spot size, fluency
range, and pulse duration of the subject device align with the predicate, thereby providing a safe hair removal solution.
Furthermore, it is important to note that these differences in spot size, fluency range, and pulse duration do not compromise the efficiency or
effectiveness of the subject device. Despite the adjustments made for enhanced safety, the subject device maintains its ability to deliver efficient
and reliable hair removal results. The modifications in these technical specifications ensure a safe treatment experience without compromising
the overall performance and efficacy of the device.
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Image /page/9/Picture/0 description: The image shows the logo for Medical San. The logo consists of a blue circle with the letters "SS" inside, stacked on top of each other. Below the circle, the words "MEDICAL SAN" are written in bold, black letters. The "SAN" portion of the text has a trademark symbol next to it.
Non-Clinical Evaluation (Performance and Safety Evaluation): C.
In order to reach high performance, safety and effectiveness the device Hakon and Hakon Smart was developed, as well produced in compliance with recognized international regulations and standards for the medical device industry.
| Description | Standard
Number |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance | IEC 60601-1 |
| Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances - Requirements and
tests | IEC 60601-1-2 |
| Medical electrical equipment - Part 2-22: Particular
requirements for basic safety and essential performance of
surgical, cosmetic, therapeutic and diagnostic laser
equipment | IEC 60601-2-22 |
| Safety Of Laser Products - Part 1: Equipment Classification
And Requirements | IEC 60825-1 |
| Biological evaluation of medical devices — Part 1: Evaluation
and testing within a risk management process | ISO 10993-1 |
d. Clinical Testing:
No clinical trial was performed.
Conclusion:
Based on compliance with the international standard and regulation mentioned above, the device Hakon and Hakon Smart demonstrate safety, effectiveness and equivalent to the predicates above.