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.

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.).

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.

AI/ML Overview

The provided text is a 510(k) Summary for the Exceed Unlimited microneedling device. It describes the device, its intended use, and compares it to a predicate device (Exceed Microneedling device) to demonstrate substantial equivalence.

However, the document does not contain specific acceptance criteria for a study demonstrating device performance, nor does it present the results of such a study in a quantitative manner (e.g., a table of performance metrics). Instead, it primarily focuses on non-clinical performance testing and risk mitigation measures to establish substantial equivalence.

Based on the provided text, I can infer some aspects and highlight what is explicitly stated versus what is absent:

1. A table of acceptance criteria and the reported device performance:

Absent. The document does not provide a table of acceptance criteria nor reported quantitative device performance metrics from a study. It only lists performance characteristics that were tested during non-clinical performance testing.

2. Sample size used for the test set and the data provenance:

Absent directly. The document mentions "non-clinical performance data" and "accuracy of needle penetration depth and puncture rate in pig skin." While this indicates the type of test, it does not specify the sample size used (e.g., number of pigs, number of punctures, number of test runs).
Data Provenance: The pig skin tests would be considered experimental/laboratory data, not human patient data. The document does not mention the country of origin for these tests. It implicitly would be from the manufacturer's testing facilities or a contracted lab. The tests are not from retrospective or prospective human clinical studies for performance metrics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Absent. This information is relevant for human-in-the-loop studies or studies relying on expert-verified data, typically clinical studies. Since the described performance testing is non-clinical (on pig skin), the concept of "experts establishing ground truth" in the diagnostic sense is not applicable here. The "ground truth" for the pig skin tests would be the measured physical properties (e.g., actual penetration depth, puncture rate) using high-speed cameras or other measurement tools.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Absent. Adjudication methods are typically used in clinical trials where multiple readers or experts assess outcomes. As the described performance testing is non-clinical/technical, this concept does not apply.

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:

Absent. This device is a microneedling device, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its function and was not performed or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable in the typical sense of AI/software. This is a hardware microneedling device. Its "performance" is evaluated by its physical characteristics (e.g., needle penetration accuracy, frequency, safety features). There isn't an "algorithm only" performance metric in the way it would apply to a diagnostic AI. The performance data mentioned (e.g., accuracy of needle penetration) are inherent to the device's mechanical operation.

7. The type of ground truth used:

For the non-clinical performance testing mentioned ("Accuracy of needle penetration depth and puncture rate in pig skin with high-speed camera measurement"), the ground truth would be physical measurements (e.g., actual depth measured from camera footage or other instruments). It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

Not applicable. This section is relevant for machine learning models. The Exceed Unlimited is a physical medical device, not a software AI model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As per point 8, there is no training set for this type of device.

In summary, based solely on the provided text, the document focuses on demonstrating substantial equivalence through non-clinical performance and safety testing, rather than presenting a performance study with acceptance criteria and quantitative results. The provided information is insufficient to complete the requested table and fully answer all questions, as many are relevant to AI/diagnostic software devices, not a microneedling device.

Summary

{0}------------------------------------------------

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"

{1}------------------------------------------------

(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

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

Enclosure

{3}------------------------------------------------

Indications for Use

Submission Number (if known)

K233709

Device Name

Exceed Unlimited

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

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:	+49 30 7676 220 171
Device Trade Name:	Exceed Unlimited
Submition Date:	24th Jan, 2024
Submission update:	16th Feb, 2024

1. Device Classification Information:

RegulationNumber	DeviceClassificationname	DeviceClass	ProductCode	Generic description	ClassificationPanel	Type
21 CFR878.4430	Microneedlingdevice foraesthetic use	Class 2	QAI	A microneedlingdevice for aestheticuse is a device usingone or more needles tomechanically punctureand injure skin tissuefor aesthetic use. Thisclassification does notinclude devicesintended fortransdermal deliveryof topical productssuch as cosmetics,drugs, or biologics.	General & PlasticSurgery	Traditional510 (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.

{5}------------------------------------------------

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.

{6}------------------------------------------------

5. Technological Characteristics

Property	Exceed Unlimited	Exceed MicroneedlingDevice	Significant differences
DeviceManufacturer	MT.DERM GmbHBlohmstr. 37 - 61,12307 Berlin,Germany	MT.DERM GmbHBlohmstr. 37 – 61,12307 Berlin,Germany	Not applicable
Device TradeName	Exceed Unlimited device	Exceed microneedling device	Not applicable
510(K) Number		(A) K182407(B) K180778	Not applicable
DeviceClassificationname	Microneedling device foraesthetic use	Microneedling device foraesthetic use	Identical
Device ProductCode	QAI	QAI	Identical
DeviceClassification	Class II	Class II	Identical
Regulationnumber	21 CFR 878.4430	21 CFR 878.4430	Identical
Use	Prescription	Prescription	Identical
Intended Locationof Use	Face	Face	Identical
Intended use andIndications	The Exceed Unlimited device isa microneedling device andaccessories intended for thetreatment of wrinkles inFitzpatrick skin types I, II and/orIII in the following facial areas:glabellar frown lines, periorbitallines and cheek folds in adultsaged 22 years or older.The Exceed Unlimited device isa microneedling device andaccessories intended to be usedas a treatment to improve theappearance of facial acne scarsin Fitzpatrick skin types I, II, IIIand IV in adults aged 22 years orolder.	K180778: The ExceedMicroneedling device is amicroneedling device andaccessories intended for thetreatment of wrinkles inFitzpatrick skin types I, II and/or III in the following facialareas: glabellar frown lines,periorbital lines and cheek foldsin adults aged 22 years or older.K182407: The ExceedMicroneedling device is amicroneedling device andaccessories intended to be usedas a treatment to improve theappearance of facial acne scarsin Fitzpatrick skin types I, II, IIIand IV in adults aged 22 yearsor older.	Identical
Geometry	6 needles, squared arrangement	6 needles, squared arrangement	Identical
Property	Exceed Unlimited	Exceed MicroneedlingDevice	Significant differences
Needle protrusionsetting	0 - 1.9 mm	0 - 1.9 mm	Identical
Maximum needlepenetration(maximum needlelength)	1.5mm	1.5 mm	Identical
Frequency	100-150 Hz (±10%)	100-150 Hz (±10%)	Identical

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for MT.DERM. The logo is in white text on a red background. The text is sans-serif and appears to be slightly blurred.

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.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for MT.DERM. The logo is white text on a red background. The text is in a sans-serif font and is centered on the image.

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 2021-07ISO 20417:2021, Corrected version 2021-12
	Sterilization validation	ISO 11135:2014 + Amd.1:2018
Cross contamination andinfection	Reprocessing validation	A cleaning validation was performed for reusable components of the device. (ReprocessingMedical Devices in Health Care Settings: Validation Methods and Labeling)
	Non-clinical performance testing	Non-clinical performance data demonstrates that the device performs as intended underanticipated conditions of use.
		The following performance characteristics are tested
		i. Accuracy of needle penetration depth and puncture rate in pig skin with high -speed camera measurement;ii. Safety features built into the device to protect against cross-contamination,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 inpig skin with highspeed camera measurement.
		Performance data supports the shelf life of the device by demonstrating continued sterility,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 orElectromagnetic interferencewith other devices	EMC testing and electricalsafety 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 underanticipated conditions of use.
		The following performance characteristics are tested
		i. Accuracy of needle penetration depth and puncture rate in pig skin with high -speed camera measurement;
Identified Risk to Health	Mitigation Measures	Evidence
		ii.Safety features built into the device to protect against cross-contamination, including fluid ingress protection due to a safety membrane; andiii.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.Exceeding safe penetration depthMechanical failureSoftware malfunction	Technological characteristics	Non-clinical performance data demonstrates that the device performs as intended under anticipated conditions of use.The following performance characteristics are tested
Exceeding safe penetration depthMechanical failureSoftware malfunction		i.Accuracy of needle penetration depth and puncture rate in pig skin with high - speed camera measurement;ii.Safety features built into the device to protect against cross-contamination, including fluid ingress protection due to a safety membrane; andiii.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 2019-02ISO 11607-2 Second edition 2019-02
	Labeling	ISO 15223-1 Fourth edition 2021-07ISO 20417:2021, Corrected version 2021-12
	Software verification, validation and hazard analysis	IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION

{9}------------------------------------------------

MT.DERM

Page 6 of 8

{10}------------------------------------------------

MT.DERM

{11}------------------------------------------------

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.

Regulation Number and Section

§ 878.4430 Microneedling device for aesthetic use.

(a)
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.(b)
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.

Indications for Use

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

Executive Summary

1. Device Classification Information:

2. Device Description

3. Indications/Intended Use

4. Predicate Device

Exceed K182407

5. Technological Characteristics

6. Substantial Equivalency and Comparison of Technological Similarities & Differences

6.1. Key Similarities.

6.2. Differences.

7. General controls and mitigation measures

7.1. Summary of Risk and mitigation measures

8. Special Controls - Non clinical performance testing

9. Clinical performance testing

10. Statement of Substantial Equivalence:

§ 878.4430 Microneedling device for aesthetic use.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW