Temporary hair reduction.
Stable long term or permanent hair reduction through selective targeting of melanin in hair follicles.
Permanent hair reduction is 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 on all skin types (Fitzpatrick I-VI) included tanned skin.
Treatment of benign pigmented lesions.
Photocoagulation of benign dermatological vascular lesions (such as port wine stains, hemangiomas, telangiectasias).

Nd:YAG 1064nm laser source:

Removal of unwanted hair for stable long term or permanent hair reduction and for treatment of PFB. The laser are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to, port wine stains, hemangioma, warts, teleangiectasias, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafè au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patient with lesions that have not responded to other treatments.

The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

Treatment of wrinkles.

Device Description

MOTUS PRO family is a medical laser family equipped with Alexandrite 755mm laser and Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. The device available with Alexandrite source only has the brand name MOTUS PRO AX.

The modifications to the device respect to DEKA Motus AZ (K211821) consist of a restyling of the device (chassis, cover plastic and GUI) and on modification to spot size ranges (new spot size available), pulse duration, 755mm maximum fluence and maximum pulse repetition rate. The modified specifications are within the range of the already cleared reference device (K233090).

The intended use of modified device, as described in the labelling has not changed as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since clearance of predicate device and reference device and considered as minor changes.

AI/ML Overview

This FDA 510(k) Premarket Notification document for the MOTUS PRO Family laser device outlines the basis for substantial equivalence to predicate devices, but does not contain a detailed study report with specific acceptance criteria and performance data in the format typically used for AI/ML device evaluations.

The provided document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (DEKA Motus AZ (K211821) and DEKA AGAIN PRO family (K233090)) based on identical or within-range technical specifications and indications for use.

Therefore, I cannot extract the specific information requested in the prompt regarding a detailed study with acceptance criteria and device performance metrics, sample sizes, ground truth establishment, or expert involvement as these details are not present in the provided text.

However, I can provide what is available regarding performance data and testing:

Summary of Performance Data (as reported in the document):

The document mentions that electrical safety, electromagnetic compatibility (EMC), and software verification and validation testing were conducted.

There is no specific clinical study data provided in this document that would allow for the construction of a "table of acceptance criteria and reported device performance" in the context of clinical efficacy or diagnostic accuracy. The substantial equivalence is based on the device's technical specifications and intended use being comparable to existing devices.

Regarding the specific questions you asked:

A table of acceptance criteria and the reported device performance:
- Not provided in the document. The document details technical specifications of the device and compares them to predicate devices, stating they are "identical" or "within the range" of the reference device. It does not present a formal table of clinical acceptance criteria and the device's performance against them.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided in the document. The document does not describe a clinical test set or its characteristics.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided in the document. No information about ground truth establishment or expert involvement for a test set is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided in the document. No information about adjudication methods is mentioned.
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:
- Not provided in the document. This document is for a laser device, not an AI/ML device for interpretation, so an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser surgical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided in the document. No information about ground truth for clinical efficacy is mentioned. The "performance data" section focuses on engineering safety and software validation, not clinical outcomes.
The sample size for the training set:
- Not applicable/provided. As this is a laser device and not an AI/ML algorithm, there isn't a "training set" in the conventional sense of machine learning.
How the ground truth for the training set was established:
- Not applicable/provided.

What the document does state regarding performance data:

Electrical safety and electromagnetic compatibility (EMC): Tested according to AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1. This ensures the device meets fundamental safety and performance requirements for medical electrical equipment and laser products.
Software Validation and Verification Testing: Conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submission for Device Software Functions." This ensures the software components of the device are reliable and function as intended.

Conclusion stated by the manufacturer:

Based on the comparison of indication for use and the technological characteristics (which are identical or within the range of predicate devices), the manufacturer concludes that the MOTUS PRO family device is safe, effective, and performs as well as the legally marketed predicate devices. This implies that compliance with the listed safety standards and software validation are sufficient for demonstrating substantial equivalence given the nature of the modifications (restyling, modifications to spot size ranges, pulse duration, maximum fluence, and maximum pulse repetition rate, all within the range of already cleared devices).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

June 21, 2024

El.En. S.p.A. Peruzzi Paolo Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FI 50041 Italy

Re: K241459

Trade/Device Name: MOTUS PRO Family 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: May 20, 2024 Received: May 23, 2024

Dear Peruzzi Paolo:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Yan Fu -S
Digitally signed by Yan Fu -S
Date: 2024.06.21 14:59:07
-04'00'

for

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

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

Enclosure

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Indications for Use

Submission Number (if known)

K241459

Device Name

MOTUS PRO Family

Indications for Use (Describe)

MOTUS PRO family is a medical laser family intended for:

Alexandrite 755nm laser source:

Temporary hair reduction.
Stable long term or permanent hair reduction through selective targeting of melanin in hair follicles.
Permanent hair reduction is 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 on all skin types (Fitzpatrick I-VI) included tanned skin.
Treatment of benign pigmented lesions.
Photocoagulation of benign dermatological vascular lesions (such as port wine stains, hemangiomas, telangiectasias).

Nd:YAG 1064nm laser source:

Removal of unwanted hair for stable long term or permanent hair reduction and for treatment of PFB. The laser are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to, port wine stains, hemangioma, warts, teleangiectasias, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafè au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patient with lesions that have not responded to other treatments.

The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

Treatment of wrinkles.

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.

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K241459 510(k) Summary

MOTUS PRO family - Special 510(k)

Submitter:

El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy

Contact:

Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi(@elen.it

Data Summary Prepared: May 20, 2024

Device Trade Name: MOTUS PRO family

Manufacturer:

DEKA M.E.L.A. srl Via Baldanzese, 17 50041 Calenzano (FI), Italy

Common Name:

Medical laser system

Regulation Number:

21 CFR 878.4810

Regulation Name:

Laser Surgical Instrument for use in General and Plastic and in Dermatology

Regulation Class: Class II

Product Code: GEX

Predicate Devices:

Primary predicate:	DEKA Motus AZ (K211821)
Reference predicate:	DEKA AGAIN PRO family (K233090)

Device Description:

MOTUS PRO family is a medical laser family equipped with Alexandrite 755mm laser and Nd:YAG 1064nm laser.

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The laser sources deliver the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. The device available with Alexandrite source only has the brand name MOTUS PRO AX.

Indications for Use:

The MOTUS PRO family is a medical device laser family intended for:

Alexandrite 755nm laser source:

· Temporary hair reduction.
Stable long term or permanent hair reduction through selective targeting of melanin in hair follicles. .
· Permanent hair reduction is 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 on all skin types (Fitzpatrick I-VI) including tanned skin.
Treatment of benign pigmented lesions. .
· Photocoaugulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

Nd:YAG 1064nm laser source:

· Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
. Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
· Coagulation and hemostasis of soft tissue.
· Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
· The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
· The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles. .

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Substantial equivalent discussion:

		Predicate Device	Reference Device
Device Trade Name	Subject Device	K211821	K233090	Comment
	MOTUS PRO family	MOTUS AZ	AGAIN PRO FAMILY
755 nm LASER
	Temporary hair reduction.	Temporary hair reduction	Temporary hair reduction.
Indications for use	Stable long-term or permanent hairreduction through selective targeting ofmelanin in hair follicles.	Stable long-term or permanent hairreduction through selective targeting ofmelanin in hair follicles.	Stable long-term or permanent hairreduction through selective targeting ofmelanin in hair follicles.	Identical
	Permanent hair reduction is defined asthe long-term, stable reduction in thenumber of hairs regrowing whenmeasured at 6,9 and 12 months after thecompletion of a treatment regime on allskin types (Fitzpatrick I-VI) includingtanned skin.	Permanent hair reduction is defined asthe long-term, stable reduction in thenumber of hairs regrowing whenmeasured at 6,9 and 12 months after thecompilation of a treatment regime, onall skin types (Fitzpatrick I-VI)including tanned skin.	Permanent hair reduction is defined asthe long-term, stable reduction in thenumber of hairs regrowing whenmeasured at 6, 9 and 12 months after thecompletion of a treatment regime on allskin types (Fitzpatrick I-VI) includedtanned skin.
	Treatment of benign pigmented lesions.	Treatment of benign pigmented lesions.	Treatment of benign pigmented lesions.
	Photocoaugulation of benigndermatological vascular lesions (such asport-wine stains, hemangiomas,telangiectasias).	Photocoaugulation of benigndermatological vascular lesions (such asport-wine stains, hemangiomas,telangiectasias).	Treatment of dermatological vascularlesions (such as port-wine stains,hemangiomas, telangiectasias).
Regulation number	21 CFR 8784810: Laser surgicalinstrument for use in general and plasticsurgery and in dermatology	21 CFR 8784810: Laser surgicalinstrument for use in general and plasticsurgery and in dermatology	21 CFR 8784810: Laser surgicalinstrument for use in general and plasticsurgery and in dermatology	Identical
Product code	GEX	GEX	GEX	Identical
		Predicate Device	Reference Device
Device Trade Name	Subject Device	K211821	K233090	Comment
	MOTUS PRO family	MOTUS AZ	AGAIN PRO FAMILY
Wavelength	755nm	755nm	755nm	Identical
Max Fluence	Stamp handpieces: 600 J/cm²Moveo handpieces: 40 J/cm²	Stamp handpieces: 200 J/cm²Moveo handpieces: 40 J/cm²	Stamp handpieces: 600 J/cm²	Identical toreference forstamphandpieces.Identical topredicate forMoveohandpieces
Handpiece Spot Sizes(diameter)	Stamp handpieces:2.5 mm5 mm7 mm10 mm12 mm14 mm15 mm16 mm18 mm20 mm22 mm24 mmMoveo handpieces:7 mm14 mm	Stamp handpieces:2.5 mm5 mm7 mm10 mm12 mm14 mm15 mm16 mm18 mm20 mmMoveo handpieces:7 mm14 mm	Stamp handpieces:2.5 mm5 mm7 mm10 mm12 mm14 mm15 mm16 mm18 mm20 mm24 mm30 mm	Within therange ofreferencedevice forstamphandpieces.Identical topredicate forMoveohandpieces.
Device Trade Name	Subject Device	Predicate Device	Reference Device	Comment
	MOTUS PRO family	K211821	K233090
		MOTUS AZ	AGAIN PRO FAMILY
Pulse Duration	0.2 to 300 ms	2 to 50 ms (single)14 to 300 ms (burst)	0.2 to 300 ms	Identical toreference
Pulse Repetition Rate	Up to 12 Hz	Up to 10 Hz	Up to 12 Hz	Identical toreference
Skin Cooling System	Yes, optional	Yes, optional	Yes, optional	Identical
Skin Cooling Temperature	15°C	15°C	-	Identical topredicate
1064 nm LASER (not available for Motus PRO AX)
Indication for use	Removal of unwanted hair, for stablelong term or permanent hair reductionand for treatment of PFB. The lasers areindicated on all Skin Types FitzpatrickI-VI including tanned skin.Photocoagulation and hemostasis ofbenign pigmented and benign vascularlesions, such as but not limited to portwine stains, hemangioma, warts,teleangiectasia, rosacea, venus lake, legveins and spider veins.Coagulation and hemostasis of softtissue.Benign pigmented lesions such as, butnot limited to, lentigos, (age spots),solar lentigos (sun spots), café au lait	Removal of unwanted hair, for stablelong term or permanent hair reductionand for treatment of PFB. The lasers areindicated on all Skin Types FitzpatrickI-VI including tanned skin.Photocoagulation and hemostasis ofbenign pigmented and benign vascularlesions, such as but not limited to portwine stains, hemangioma, warts,teleangiectasia, rosacea, venus lake, legveins and spider veins.Coagulation and hemostasis of softtissue.Benign pigmented lesions such as, butnot limited to, lentigos, (age spots),solar lentigos (sun spots), café au lait	Removal of unwanted hair for stablelong term or permanent hair reductionand for treatment of PFB. The lasers areindicated on all Skin Types FitzpatrickI-VI including tanned skin.Photocoagulation and hemostatis ofpigmented and vascular lesions. Such asbut not limited to, port wine stains,hemangioma, warts, teleangiectasia,rosacea, venus lake, leg veins and spiderveins.Coagulation and hemostasis of softtissue.Benign pigmented lesions such as, butnot limited to lentigos, (age spots), solarlentigos (sun spots), café au lait	Identical
		Predicate Device	Reference Device
Device Trade Name	Subject Device	K211821	K233090	Comment
	MOTUS PRO family	MOTUS AZ	AGAIN PRO FAMILY
	macules, seborrheic keratosis, nevi,cloasma, verrucae, skin tags, keratosisand plaques.The laser is indicated for benignpigmented lesions to reduce lesion size,for patients with lesions that wouldpotentially benefit from aggressivetreatment, and for patients with lesionsthat have not responded to other lasertreatments.The laser is also indicated for thereduction of red pigmentation inhypertrophic and keloid scars wherevascularity is an integral part of the	macules, seborrheic keratosis, nevi,cloasma, verrucae, skin tags, keratosisand plaques.The laser is indicated for benignpigmented lesions to reduce lesion size,for patients with lesions that wouldpotentially benefit from aggressivetreatment, and for patients with lesionsthat have not responded to other lasertreatments.The laser is also indicated for thereduction of red pigmentation inhypertrophic and keloid scars wherevascularity is an integral part of the	macules, seborrheic keratosis, nevi,cloasma, verrucae, skin tags, keratosisand plaques.Pigmented lesions to reduce lesion size,for patients with lesions that wouldpotentially benefit from aggressivetreatment, and for patients with lesionsthat have not responded to other lasertreatment.Reduction of red pigmentation inhypertrophic and keloid scars wherevascularity is an integral part of thescar.Treatment of wrinkles.
	scar.Treatment of wrinkles.	scar.Treatment of wrinkles.
Regulation number	21 CFR 8784810: Laser surgicalinstrument for use in general and plasticsurgery and in dermatology	21 CFR 8784810: Laser surgicalinstrument for use in general and plasticsurgery and in dermatology	21 CFR 8784810: Laser surgicalinstrument for use in general and plasticsurgery and in dermatology	Identical
Product code	GEX	GEX	GEX	Identical
Wavelength	1064 nm	1064 nm	1064 nm	Identical
Max Fluence	Stamp handpieces: 600 $J/cm^2$Moveo handpieces: 50 $J/cm^2$	Stamp handpieces: 600 $J/cm^2$Moveo handpieces: 50 $J/cm^2$	Stamp handpieces: 600 $J/cm^2$	Identical topredicate.
		Predicate Device	Reference Device
Device Trade Name	Subject Device	K211821	K233090	Comment
	MOTUS PRO family	MOTUS AZ	AGAIN PRO FAMILY
Handpiece Spot Sizes	Stamp handpieces:	Stamp handpieces:	Stamp handpieces:	Within the
(diameter)	2.5 mm	2.5 mm	2.5 mm	range of
	5 mm	5 mm	5 mm	reference
	7 mm	7 mm	7 mm	device forstamp
	10 mm	10 mm	10 mm	handpieces.
	12 mm	12 mm	12 mm	Identical to
	14 mm	14 mm	14 mm	predicate for
	15 mm	15 mm	15 mm	Moveo
	16 mm	16 mm	16 mm	handpieces.
	18 mm	18 mm	18 mm
	20 mm	20 mm	20 mm
	22 mm	Moveo handpieces:	22 mm
	24 mm	5 mm	24 mm
	Moveo handpieces:	14 mm	30 mm
	5 mm
	14 mm
Pulse Duration	0.2 to 300 ms	2 to 300 ms	0.2 to 300 ms	Identical toreference
Pulse Repetition Rate	Up to 12 Hz	Up to 10 Hz	Up to 12 Hz	Identical toreference
Skin Cooling System	Yes, optional	Yes, optional	Yes, optional	Identical
Skin Cooling Temperature	15°C	15°C	-	Identical topredicate

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The MOTUS PRO family is substantially equivalent to a legally marketed devices DEKA Motus AZ (K21) and DEKA AGAN PRO family (K233990).

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Performance Data:

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the MOTUS PRO family device, according to the following standards:

AAMI/ANSI ES60601-1 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and ● Essential Performance - Collateral standard: Electromagnetic Disturbances - Requirements and tests.
IEC 60601-2-22 Medical Electrical Equipment Part 2-2: Particular requirements for basic safety . and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
IEC 60825-1 Safety of laser products Part 1: Equipment classification and requirements. .

Software Validation and Verification Testing

Software verification and validation testing were conducted and documented as a recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submission for Device Software Functions".

Conclusion:

Based on the comparison of indication for use and the technological characteristics, we can conclude that MOTUS PRO family device is safe, as effective, and performs as well as the legally marketed predicate device (K211821) and reference device (K233090).

Additional Information:

None

Regulation Number and Section

§ 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.