Exceed Unlimited

K233709 · Mt. Derm GmbH · QAI · Feb 23, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K233709
• Device Name: Exceed Unlimited
• Applicant: Mt. Derm GmbH
• Product Code: QAI · General, Plastic Surgery
• Decision Date: Feb 23, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4430
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Exceed Unlimited is a microneedling device and accessories intended for the treatment of wrinkles in Fitzpatrick skin types I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older. The Exceed Unlimited is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III and IV in adults aged 22 years or older.

Device Story

Exceed Unlimited is a handheld, battery-powered microneedling device for aesthetic use. It utilizes a sterile, single-use safety needle cartridge containing 6 stainless steel needles to create microscopic punctures in epidermal and dermal skin layers. The device features an adjustable needle protrusion (0.0–1.9 mm) and adjustable frequency (100–150 Hz). Operated by a clinician, the device is used on the face to treat wrinkles and acne scars. The handpiece includes a motor and display for frequency settings. The device is powered by a 3.7V Li-Ion battery, rechargeable via a wall-socket transformer. The safety needle cartridge includes an internal membrane to prevent fluid ingress and cross-contamination. The device is a prescription-only system. Clinical benefit is achieved through mechanical skin injury, which stimulates tissue response to improve skin appearance.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance testing, including biocompatibility (ISO 10993 series), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and bench testing (needle penetration accuracy and puncture rate in pig skin using high-speed camera measurement).

Technological Characteristics

Handheld microneedling device; 6 stainless steel needles in squared arrangement; max penetration 1.5mm; frequency 100-150 Hz; Li-Ion battery powered (3.7V); sterile single-use cartridge with safety membrane; ISO 10993 biocompatibility; IEC 60601-1 electrical safety; IEC 62304 software compliance.

Indications for Use

Indicated for adults aged 22+ with Fitzpatrick skin types I-III for treatment of facial wrinkles (glabellar, periorbital, cheek folds) and Fitzpatrick skin types I-IV for improvement of facial acne scars.

Regulatory Classification

Identification

A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.

Special Controls

The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate. Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Accuracy of needle penetration depth and puncture rate; (ii) Safety features built into the device to protect against cross-contamination, including fluid ingress protection; and (iii) Identification of the maximum safe needle penetration depth for the device for the labeled indications for use. Performance data must demonstrate the sterility of the patient-contacting components of the device. Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life. Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device. Software verification, validation, and hazard analysis must be performed for all software components of the device. The patient-contacting components of the device must be demonstrated to be biocompatible. Performance data must validate the cleaning and disinfection instructions for reusable components of the device. Labeling must include the following: (i) Information on how to operate the device and its components and the typical course of treatment; (ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate; (iii) Validated methods and instructions for reprocessing of any reusable components: (iv) Disposal instructions; and (v) Shelf life. Patient labeling must be provided and must include: (i) Information on how the device operates and the typical course of treatment; (ii) The probable risks and benefits associated with use of the device; and (iii) Post-operative care instructions.

*Classification.* Class II (special controls). The special controls for this device are:(1) The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate. (2) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Accuracy of needle penetration depth and puncture rate; (ii) Safety features built into the device to protect against cross-contamination, including fluid ingress protection; and (iii) Identification of the maximum safe needle penetration depth for the device for the labeled indications for use. (3) Performance data must demonstrate the sterility of the patient-contacting components of the device. (4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life. (5) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device. (6) Software verification, validation, and hazard analysis must be performed for all software components of the device. (7) The patient-contacting components of the device must be demonstrated to be biocompatible. (8) Performance data must validate the cleaning and disinfection instructions for reusable components of the device. (9) Labeling must include the following: (i) Information on how to operate the device and its components and the typical course of treatment; (ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate; (iii) Validated methods and instructions for reprocessing of any reusable components; (iv) Disposal instructions; and (v) A shelf life. (10) Patient labeling must be provided and must include: (i) Information on how the device operates and the typical course of treatment; (ii) The probable risks and benefits associated with use of the device; and (iii) Postoperative care instructions.

Predicate Devices

• Exceed (K182407)

Reference Devices

• Exceed Microneedling device (K180778)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

February 23, 2024

Mt.Derm GmbH Stefan Polland Regulatory Affairs Manager Blohmstr. 37-61 Berlin, 12307 Germany

Re: K233709

Trade/Device Name: Exceed Unlimited Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling Device For Aesthetic Use Regulatory Class: Class II Product Code: OAI Dated: January 24, 2024 Received: January 24, 2024

Dear Stefan Polland:

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.

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"

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(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 OS 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.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical

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and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Submission Number (if known)

K233709

Device Name

Exceed Unlimited

Indications for Use (Describe)

The Exceed Unlimited is a microneedling device and accessories intended for the treatment of wrinkles in Fitzpatrick skin types I. Il and/or III in the following facial areas: qlabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.

The Exceed Unlimited is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III and IV in adults aged 22 years or older.

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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MT.DERM

510(k) Summary K233709

# Executive Summary

| Submitter's Name: | MT.DERM GmbH |
|----------------------|----------------------------------------|
| Submitter's Contact: | Stefan Polland |
| Submitter's Address: | Blohmstr. 37-61, 12307 Berlin, Germany |
| Submitter's Telefon: | [phone] |
| Device Trade Name: | Exceed Unlimited |
| Submition Date: | 24th Jan, 2024 |
| Submission update: | 16th Feb, 2024 |

## 1. Device Classification Information:

| Regulation<br>Number | Device<br>Classification<br>name | Device<br>Class | Product<br>Code | Generic description | Classification<br>Panel | Type |
|----------------------|----------------------------------------------|-----------------|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------|
| 21 CFR<br>878.4430 | Microneedling<br>device for<br>aesthetic use | Class 2 | QAI | A microneedling<br>device for aesthetic<br>use is a device using<br>one or more needles to<br>mechanically puncture<br>and injure skin tissue<br>for aesthetic use. This<br>classification does not<br>include devices<br>intended for<br>transdermal delivery<br>of topical products<br>such as cosmetics,<br>drugs, or biologics. | General & Plastic<br>Surgery | Traditional<br>510 (k) |

# 2. Device Description

The Exceed Unlimited device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles.

The Exceed Unlimited device consists of 7 component parts; Handpiece, sterile single use Safety needle cartridge, Handpiece holder, Barrier Sleeve, Battery, Charger incl. USB cable, power supply. The handpiece contains a motor that moves the needles. The handpiece receives power via a Li-Ion battery with an output of 3,7 V. The battery charger receives power from a standard 100-240V, 50-60Hz, 0.45A wall socket transformer with an USB output of 5 V, 3.2A.

The frequency of the handpiece can be adjusted from 100-150Hz and is indicated on a display. The needle penetration is adjusted by the needle protrusion setting dial, which can be adjusted between 0.0 (min.) and 1.9 mm (max.).

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The standard safety needle cartridge (6-needle plate) contains 6 stainless steel microneedles of 1.5 mm length (0.35 mm gauge) and an internal safety membrane. The safety needle cartridge is screwed into the handpiece. The safety needle cartridge is sterile and for single use ONLY.

# 3. Indications/Intended Use

The Exceed Unlimited is a microneedling device and accessories intended for the treatment of wrinkles in Fitzpatrick skin types I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.

The Exceed Unlimited is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, III, III and IV in adults aged 22 years or older.

The device is a prescriptive device and complies with 21CFR 801.109.

# 4. Predicate Device

# Exceed K182407

The Exceed Microneedling device is a microneedling device and accessories intended for the treatment of wrinkles in Fitzpatrick skin types I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.

The Exceed Microneedling device is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, III and IV in adults aged 22 years or older.

Intended use applies exclusively to the following patient groups: Adult men and women aged 22 years or older who are in good health.

The device is a prescription device and complies with 21CFR 801.109.

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# 5. Technological Characteristics

| Property | Exceed Unlimited | Exceed Microneedling<br>Device | Significant differences |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Device<br>Manufacturer | MT.DERM GmbH<br>Blohmstr. 37 - 61,<br>12307 Berlin,<br>Germany | MT.DERM GmbH<br>Blohmstr. 37 – 61,<br>12307 Berlin,<br>Germany | Not applicable |
| Device Trade<br>Name | Exceed Unlimited device | Exceed microneedling device | Not applicable |
| 510(K) Number | | (A) K182407<br>(B) K180778 | Not applicable |
| Device<br>Classification<br>name | Microneedling device for<br>aesthetic use | Microneedling device for<br>aesthetic use | Identical |
| Device Product<br>Code | QAI | QAI | Identical |
| Device<br>Classification | Class II | Class II | Identical |
| Regulation<br>number | 21 CFR 878.4430 | 21 CFR 878.4430 | Identical |
| Use | Prescription | Prescription | Identical |
| Intended Location<br>of Use | Face | Face | Identical |
| Intended use and<br>Indications | The Exceed Unlimited device is<br>a microneedling device and<br>accessories intended for the<br>treatment of wrinkles in<br>Fitzpatrick skin types I, II and/or<br>III in the following facial areas:<br>glabellar frown lines, periorbital<br>lines and cheek folds in adults<br>aged 22 years or older.<br>The Exceed Unlimited device is<br>a microneedling device and<br>accessories intended to be used<br>as a treatment to improve the<br>appearance of facial acne scars<br>in Fitzpatrick skin types I, II, III<br>and IV in adults aged 22 years or<br>older. | K180778: The Exceed<br>Microneedling device is a<br>microneedling device and<br>accessories intended for the<br>treatment of wrinkles in<br>Fitzpatrick skin types I, II and/<br>or III in the following facial<br>areas: glabellar frown lines,<br>periorbital lines and cheek folds<br>in adults aged 22 years or older.<br>K182407: The Exceed<br>Microneedling device is a<br>microneedling device and<br>accessories intended to be used<br>as a treatment to improve the<br>appearance of facial acne scars<br>in Fitzpatrick skin types I, II, III<br>and IV in adults aged 22 years<br>or older. | Identical |
| Geometry | 6 needles, squared arrangement | 6 needles, squared arrangement | Identical |
| Property | Exceed Unlimited | Exceed Microneedling<br>Device | Significant differences |
| Needle protrusion<br>setting | 0 - 1.9 mm | 0 - 1.9 mm | Identical |
| Maximum needle<br>penetration<br>(maximum needle<br>length) | 1.5mm | 1.5 mm | Identical |
| Frequency | 100-150 Hz (±10%) | 100-150 Hz (±10%) | Identical |

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## 6. Substantial Equivalency and Comparison of Technological Similarities & Differences

#### 6.1. Key Similarities.

- i. The device classification (generic description) and basic technologies are equivalent in that both devices are micro needling systems containing >1 needle that mechanically punctures or injures the skin for aesthetic use.
- ii. Identical intended use.
- iii. The depth of penetration of the needles (needle length) is equivalent 1.5mm
- iv. Intended for prescription use.
- v. Location of use (Face)
- vi. Identical needle configuration
- vii. Identical needle protrusion setting
- viii.Identical Frequency

#### 6.2. Differences.

Although the systems share the basic technology they do differ in two major areas:

- i. Power Supply - Exceed Microneedling device was supplied directly by a wall plug. Exceed Unlimited is supplied by rechargeable battery.
- ii. Control - Exceed Microneedling device was controlled by a separate control unit. Exceed Unlimited is directly controlled with the hand piece.

This difference has been addressed by the manufacturer through the applicable safety standards (General controls and mitigation measures).

Although there are differences between the proposed device, Exceed Unlimited, and predicate device, Exceed Microneedling Device (K182407), General controls of the FD&C Act and "Special controls" listed below demonstrate that the Exceed Unlimited device raises no new questions in relation to safety and efficacy compared to the predicate device.

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## 7. General controls and mitigation measures

To demonstrate safe and effective performance and support substantial equivalence has undergone a number of non-clinical performance tests in line with recognized standards in terms of general requirements, biocompatibility, electrical safety and software. The following non-clinical performance data is provided in support of the substantial equivalence determination.

### 7.1. Summary of Risk and mitigation measures

| Identified Risk to Health | Mitigation Measures | Evidence |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Adverse tissue reaction | Biocompatibility evaluation | ISO 10993-5 Third edition 2009-06-01 |
| | | ISO 10993-7:2008 |
| | | ISO 10993-10: 2010 |
| | | ISO 10993-11:2017 |
| | Labeling | ISO 15223-1 Fourth edition 2021-07<br>ISO 20417:2021, Corrected version 2021-12 |
| | Sterilization validation | ISO 11135:2014 + Amd.1:2018 |
| Cross contamination and<br>infection | Reprocessing validation | A cleaning validation was performed for reusable components of the device. (Reprocessing<br>Medical Devices in Health Care Settings: Validation Methods and Labeling) |
| | Non-clinical performance testing | Non-clinical performance data demonstrates that the device performs as intended under<br>anticipated conditions of use. |
| | | The following performance characteristics are tested |
| | | i. Accuracy of needle penetration depth and puncture rate in pig skin with high -<br>speed camera measurement;<br>ii. Safety features built into the device to protect against cross-contamination,<br>including fluid ingress protection due to a safety membrane; and |
| Identified Risk to Health | Mitigation Measures | Evidence |
| | Shelf life testing | iii. Identification of the maximum safe needle penetration depth for the device in<br>pig skin with highspeed camera measurement. |
| | | Performance data supports the shelf life of the device by demonstrating continued sterility,<br>package integrity, and device functionality over the intended shelf life |
| | | according to |
| | | ISO 11607-1 Second edition 2019-02 |
| | | ISO 11607-2 Second edition 2019-02 |
| | Labeling | Section 13 Proposed labeling |
| | | ISO 15223-1 Fourth edition 2021-07 |
| | | ISO 20417:2021, Corrected version 2021-12 |
| | | |
| Electrical shock or<br>Electromagnetic interference<br>with other devices | EMC testing and electrical<br>safety testing | IEC 60601-1:2005/AMD2:2020 |
| | | IEC 60601-1-2:2014/AMD1:2020 |
| | | IEC 60601-1-6:/AMD2:2020 |
| | Labeling | ISO 15223-1 Fourth edition 2021-07 |
| | | ISO 20417:2021, Corrected version 2021-12 |
| | | IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION |
| | Non-clinical performance testing | Non-clinical performance data demonstrates that the device performs as intended under<br>anticipated conditions of use. |
| | | The following performance characteristics are tested |
| | | i. Accuracy of needle penetration depth and puncture rate in pig skin with high -<br>speed camera measurement; |
| Identified Risk to Health | Mitigation Measures | Evidence |
| | | ii.<br>Safety features built into the device to protect against cross-contamination, including fluid ingress protection due to a safety membrane; and<br>iii.<br>Identification of the maximum safe needle penetration depth for the device in pig skin with highspeed camera measurement. |
| Damage to underlying tissue including nerves and blood vessels, scarring and hyper and hypopigmentation.<br>Exceeding safe penetration depth<br>Mechanical failure<br>Software malfunction | Technological characteristics | Non-clinical performance data demonstrates that the device performs as intended under anticipated conditions of use.<br>The following performance characteristics are tested |
| Exceeding safe penetration depth<br>Mechanical failure<br>Software malfunction | | i.<br>Accuracy of needle penetration depth and puncture rate in pig skin with high - speed camera measurement;<br>ii.<br>Safety features built into the device to protect against cross-contamination, including fluid ingress protection due to a safety membrane; and<br>iii.<br>Identification of the maximum safe needle penetration depth for the device in pig skin with highspeed camera measurement. |
| | Shelf life testing | ISO 11607-1 Second edition 2019-02<br>ISO 11607-2 Second edition 2019-02 |
| | Labeling | ISO 15223-1 Fourth edition 2021-07<br>ISO 20417:2021, Corrected version 2021-12 |
| | Software verification, validation and hazard analysis | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION |

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MT.DERM

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MT.DERM

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## 8. Special Controls - Non clinical performance testing

In addition to the general standards and risk mitigation measures identified above, the Exceed Microneedling device has been subjected to the special controls outlined in 21 CFR 878.4430.

### 9. Clinical performance testing

Not applicable.

## 10. Statement of Substantial Equivalence:

513(i) of the FD&C Act (21 U.S.C. 360c(i) states that for substantial equivalence a proposed device is required to have the same intended use and similar technological characteristics as the predicate device. Where there are differences in technological characteristics, these can be negated by appropriate clinical or scientific data demonstrating that the proposed device is as safe and effective as the predicate device, and that the proposed device does not raise any different questions of safety and effectiveness than the predicate device for the same intended use.

MT.DERM GmbH has demonstrated that the Exceed Unlimited device has the same generic classification (generic description) and basic technologies as the predicate device Exceed microneedling system (K182407). Both devices are micro needling systems containing >1 needle that mechanically punctures or injures the skin for aesthetic use. Both devices have used needle depths of up to 1.5mm in clinical investigations.

Where there are differences between the Exceed Unlimited device and the predicate MT.DERM GmbH has conducted substantial non-clinical performance testing applicable to those general and special controls deemed necessary by the agency for this product classification and has determined that the Exceed Unlimited device raises no new questions relating to safety or efficacy and therefore has demonstrated that the Exceed Unlimited device is substantially equivalent to the referenced predicate K182407.