Who is the manufacturer of DEKA Motus AZ?

El.En Electronic Engineering Spa filed the 510(k) submission for DEKA Motus AZ (K211821).

What is the FDA product code for DEKA Motus AZ?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for DEKA Motus AZ?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like DEKA Motus AZ?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DEKA Motus AZ

K211821 · El.En Electronic Engineering Spa · GEX · Jul 6, 2021 · General, Plastic Surgery

Device Facts

Record ID	K211821
Device Name	DEKA Motus AZ
Applicant	El.En Electronic Engineering Spa
Product Code	GEX · General, Plastic Surgery
Decision Date	Jul 6, 2021
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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. Treatment of wrinkles. 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 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), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. The laser is indicated for benign pigmented 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.

Device Story

DEKA Motus AZ is a dual-wavelength laser system (Alexandrite 755nm and Nd:YAG 1064nm) for dermatological and surgical applications. Device delivers laser energy via user-replaceable optical fibers and interchangeable handpieces with electronic spot recognition. System includes integrated skin cooling (15°C). Operated by clinicians in a professional setting. Modifications from predicate include chassis/GUI restyling and updated Moveo handpiece options (new spot sizes/spacers). Spacer material is biocompatible Anticorodal 6082. Device provides stable long-term hair reduction, lesion treatment, and soft tissue coagulation. Clinicians use the system to target melanin or vascular structures; output affects clinical decision-making by providing non-invasive therapeutic options for dermatological conditions.

Clinical Evidence

Bench testing only. Performance verified through electrical safety (ANSI AAMI ES60601-1), EMC (IEC 60601-1-2), laser safety (IEC 60825-1, IEC 60601-2-22), and software verification/validation.

Technological Characteristics

Dual-source laser (Alexandrite 755nm, Nd:YAG 1064nm). Fluence: 2-200 J/cm² (Alexandrite), 2-600 J/cm² (Nd:YAG). Pulse duration: 0.2-50 ms. Repetition rate: up to 10 Hz. Integrated/external skin cooling (15°C). Handpieces feature electronic spot recognition. Spacer material: Anticorodal 6082. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1.

Indications for Use

Indicated for patients of all skin types (Fitzpatrick I-VI), including tanned skin, requiring hair reduction, treatment of benign pigmented/vascular lesions, soft tissue coagulation/hemostasis, treatment of PFB, and reduction of red pigmentation in hypertrophic/keloid scars.

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

DEKA MOTUS AY (K181486)

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Submission Summary (Full Text)

{0}------------------------------------------------ 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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. July 6, 2021 El.En Electronic Engineering SPA Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, Florence 50041 Italy Re: K211821 Trade/Device Name: DEKA Motus AZ Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: June 8, 2021 Received: June 11, 2021 Dear Paolo Peruzzi: 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 (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 located 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. {1}------------------------------------------------ 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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. Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211821 Device Name DEKA Motus AZ #### Indications for Use (Describe) 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. Treatment of wrinkles. 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 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), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. The laser is indicated for benign pigmented 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. Type of Use (Select one or both, as applicable) X 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." {3}------------------------------------------------ # 510(K) Summary # DEKA MOTUS AZ - 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 ## Date Summary Prepared: June 25, 2021 ## Device Trade Name: DEKA Motus AZ ## Common Name: Powered Laser Surgical Instrument #### Classification Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology #### Product Code: GEX #### Regulatory Class: Class II Classification Number: 21 CFR 878.4810 Predicate Device: DEKA MOTUS AY (K181486) ## Device Description: Motus AZ is a medical device equipped with Alexandrite 755nm laser and Nd: YAG 1064nm laser. {4}------------------------------------------------ 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 modifications to the device consist on a restyling of the device (chassis, cover plastics and GUI) and on modifications to Moveo handpiece (new spot sizes available and new optional spacer). The spot size and the fluences are within the range of the already cleared device (K181486). The optional spacer is made of a biocompatible material (Anticorodal 6082), already used in previously cleared devices for the same type of contact (K192539, K172362, K172362, K133895). The intended use of the modified devices, 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 predicate device clearance and considered as minor changes. ## Indications for Use: ## 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. Treatment of wrinkles. 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 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), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. {5}------------------------------------------------ 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. {6}------------------------------------------------ #### K211821 # Comparison With The Predicate Device: ## GENERAL SPECIFICATIONS | Device Trade Name | Proposed Device DEKA Motus AZ | Predicate Device DEKA MOTUS AY (K181486) | Comment | |-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | Weight | Approx. 100 kg | Approx. 90 kg | The variation to the weight does not affect safety and effectiveness of the device | | Dimensions (cm) | 114x45x94 (HxWxD) | 95x51x83 (HxWxD) | The variation to the dimensions does not affect safety and effectiveness of the device | | Mains voltage | 230 V~single phase, 50-60 Hz | 230 V~single phase, 50-60 Hz | Identical | | Breaker | 16 A | 16 A | Identical | | Operating environmental conditions | 15-35 °C; 30%-75% rel. humidity, 700-1060 hPa | 15-35 °C; 30%-75% rel. humidity, 700- 1060 hPa | Identical | | Transport and storage conditions | 5-50 °C; 10-90% humidity, 700-1060 hPa | 5-50 °C; 10-90% humidity, 700-1060 hPa | Identical | | Device Trade Name | Proposed Device DEKA Motus AZ | Predicate Device DEKA MOTUS AY (K181486) | Comment | | Indications for Use | 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. Treatment of wrinkles. Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). | 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. Treatment of wrinkles. Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). | Identical | | Regulation number | 21 CFR 878.4810: Laser surgical instrument for use in general and plastic surgery and in dermatology | 21 CFR 878.4810: Laser surgical instrument for use in general and plastic surgery and in dermatology | Identical | | Product Code | GEX | GEX | Identical | | Device Trade Name | Proposed Device DEKA Motus AZ | Predicate Device DEKA MOTUS AY (K181486) | Comment | | Laser Type | Alexandrite | Alexandrite | Identical | | Wavelength (nm) | 755 nm | 755 nm | Identical | | Fluence (J/cm2) | 2-200 J/cm² | 2-200 J/cm² | Identical | | Handpiece Spot Sizes (diameter millimeter) | 2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 7, 14 mm) | 2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 14 mm) | Identical overall spot size range | | Pulse Duration (milliseconds) | 2 to 50 ms | 2 to 50 ms | Identical | | Pulse Repetition Rate (Hz) | up to 10 Hz | up to 10 Hz | Identical | | Skin Cooling System | Yes (handpiece integrated and external) | Yes (handpiece integrated and external) | Identical | | Skin Cooling Temperature | 15°C | 15°C | Identical | | Device Trade Name | Proposed Device | Predicate Device | Comment | | Indications for Use | 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. | 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. | Identical | | | 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. | 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. | Coagulation and hemostasis of soft tissue. | | | | Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. | Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (sun spots), cafe 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 | The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive | | | Device Trade Name | Proposed Device | Predicate Device | Comment | | | DEKA Motus AZ | DEKA MOTUS AY (K181486) | | | | treatment, and for patients with lesions that have not responded to other laser treatments. | 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. | 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. | | | Regulation number | 21 CFR 878.4810: Laser surgical instrument for use in general and plastic surgery and in dermatology | 21 CFR 878.4810: Laser surgical instrument for use in general and plastic surgery and in dermatology | Identical | | Product Code | GEX | GEX | Identical | | Laser Type | Nd:YAG | Nd:YAG | Identical | | Wavelength (nm) | 1064 nm | 1064 nm | Identical | | Fluence (J/cm²) | 2-600 J/cm2 | 2-600 J/cm2 | Identical | | Device Trade Name | Proposed Device | Predicate Device | Comment | | | DEKA Motus AZ | DEKA MOTUS AY (K181486) | | | Handpiece Spot Sizes (diameter millimeter) | 2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 5, 14 mm) | 2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 14 mm) | Identical overall spot size range | | Pulse Duration (milliseconds) | 0.2 to 50 ms | 0.2 to 50 ms | Identical | | Pulse Repetition Rate (Hz) | up to 10 Hz | up to 10 Hz | Identical | | Skin Cooling System | Yes (handpiece integrated and external) | Yes (handpiece integrated and external) | Identical | | Skin Cooling Temperature | 15°C | 15°C | Identical | {7}------------------------------------------------ 755 nm LASER {8}------------------------------------------------ {9}------------------------------------------------ #### 1064 nm LASER {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ # Performance data: ## Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted on the Motus AZ device, according to the following standards: - . ANSI AAMI ES60601-1Medical 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. ## Software Validation and Verification Testing Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." ## Additional non-clinical testing conducted Additional tests were conducted on the Motus AZ device, according to the following standards: - . IEC 60601-2-22: Medical electrical equipment - Part 2-22: 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. ## Conclusion: Based on the comparison of indications for use and the technological characteristics, we can conclude that DEKA Motus AZ is as safe, as effective, and performs as well as the legally marketed predicate device (K181486). #### Additional Information: None.