SmoothSkin Pure Switch (SSC1)

K243362 · Cyden Limited · OHT · Nov 27, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K243362
• Device Name: SmoothSkin Pure Switch (SSC1)
• Applicant: Cyden Limited
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Nov 27, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SmoothSkin Pure Switch is intended for the removal of unwanted hair. The SmoothSkin Pure Switch is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Device Story

SmoothSkin Pure Switch (SSC1) is an over-the-counter, mains-powered Intense Pulsed Light (IPL) device for home use. Device consists of a handset, hardwired base unit, and AC power cord. Operation involves converting AC mains power to DC to charge an electrical storage capacitor, which powers a flash lamp to produce optical output. Light energy is applied to the skin surface; melanin in the hair shaft absorbs the light, converting it to heat to reduce hair regrowth. Device includes new cooling function and attachments for difficult-to-reach areas. User operates device at home to achieve long-term hair reduction.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including electrical safety (IEC 60601-1, IEC 60601-2-57, IEC 60601-2-83), electromagnetic compatibility (IEC 60601-1-2), photobiological safety (IEC 62471), and biocompatibility (ISO 10993-1, -5, -10).

Technological Characteristics

Mains-powered IPL device. Energy source: AC-to-DC converter charging an electrical storage capacitor for flash lamp output. Energy output: 2-6 J/cm². Includes cooling function and attachments. Compliant with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-57, IEC 60601-2-83, IEC 60601-1-2, IEC 62471. Biocompatibility per ISO 10993-1, -5, -10.

Indications for Use

Indicated for removal of unwanted hair and permanent reduction in hair regrowth in individuals seeking home-use hair removal.

Regulatory Classification

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.

Predicate Devices

• SmoothSkin Pure Adapt (K233782)
• SmoothSkin Gold (K143003)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 27, 2024

CyDen Limited Adam Stephens Regulatory Engineer Block A, Bay Studios Business Park, Fabian Way, SA1 8QB Swansea. United Kingdom

Re: K243362

Trade/Device Name: SmoothSkin Pure Switch (SSC1) 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: OHT Dated: October 29, 2024 Received: October 29, 2024

Dear Adam Stephens:

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/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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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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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.

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-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Yan Fu J = S Date: 2024.11.27 14:54:39
Date: 2024.11.27 14:54:39
-05:00 Date: 2024.11.27 14:54:39
-05:00 -05:00' Yan -05'00'

for Tanisha Hithe

Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & 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) K243362

Device Name SmoothSkin Pure Switch (SSC1)

Indications for Use (Describe)

The SmoothSkin Pure Switch is intended for the removal of unwanted hair. The SmoothSkin Pure Switch is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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| 510(k) #: | 510(k) Summary | | Prepared on: 2024-10-29 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------|-------------------------|
| Contact Details | 21 CFR 807.92(a)(1) | | |
| Applicant Name | CyDen Limited | | |
| Applicant Address | Block A, Bay Studios Business Park, Fabian Way, SA1 8QB Swansea United Kingdom | | |
| Applicant Contact Telephone | [phone] | | |
| Applicant Contact | Mr. Adam Stephens | | |
| Applicant Contact Email | [e-mail] | | |
| Device Name | 21 CFR 807.92(a)(2) | | |
| Device Trade Name | SmoothSkin Pure Switch (SSC1) | | |
| Common Name | Laser surgical instrument for use in general and plastic surgery and in dermatology | | |
| Classification Name | Light Based Over-The-Counter Hair Removal | | |
| Regulation Number | 878.4810 | | |
| Product Code(s) | OHT | | |
| Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | | | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K233782 | SmoothSkin Pure Adapt | OHT | |
| K143003 | SmoothSkin Gold | OHT, GEX, Q | |
| Device Description Summary | 21 CFR 807.92(a)(4) | | |
| The SSC1 device is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use. | | | |
| The device is mains powered and consists of the handset, hardwired base unit and AC power cord. AC mains is fed into the AC to DC converter that is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp. | | | |
| Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy (below the surface of the skin), which reduces the hairs growing back. | | | |
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | | |
| The SmoothSkin Pure Switch is intended for the removal of unwanted hair. The SmoothSkin Pure Switch is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. | | | |

Indications for Use Comparison

21 CFR 807.92(a)(5)

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# Technological Comparison

The SSC1 device has the same following characteristics.

- The same intended use.
- Operates with the same mode of actions.
- Has the same technological characteristics.
- Has the same shelf-life.
- Is manufactured and packed in the same manner.
- Has the same safety features.

The following modification have been made to the SSC1 device.

- Electronic design changes to incorporate a cooling function.
- Attachments to allow the user to use the device in difficult areas.

- Energy Output Parameters 2 - 6J/cm2 vs 3-6J/cm2 for predicate

# Non-Clinical and/or Clinical Tests Summary & Conclusions

The device is compliant with the following Electrical Safety and Electromagnetic Compatibility standards.

1) AAM / IEC 60601-1 : Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance 2) IEC 60601-1-6 : Medical Electrical Equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

3) IEC 60601-2-57 : Medical Electrical Equipment : Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use

4) IEC 60601-2-83 : Medical Electrical Equipment Part 2-83: Particular requirement for the basic safety and essential performance of home light therapy equipment

5) IEC 60601-1-2 : Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

6) IEC 62471 : Photobiological safety of lamps and lamp systems

The device is compliant with the following Biocompatibility standards

1) ISO 10993-1 : Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

2) ISO 10993-5 : Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

3) ISO 10993-10 : Biological evaluation of medical devices Part 10: Tests for skin sensitization

21 CFR 807.92(a)(6)

21 CFR 807.92(b)