(29 days)
No
The summary focuses on laser technology, hardware modifications, and standard software verification, with no mention of AI or ML.
Yes
The device is intended for various medical treatments, including the reduction of red pigmentation in hypertrophic and keloid scars, and the treatment of wrinkles. These indications point to therapeutic purposes.
No
The provided text describes the MOTUS PRO family device as a medical laser system used for various aesthetic and medical treatments such as hair reduction, treatment of pigmented lesions, and photocoagulation of vascular lesions. Its "Intended Use / Indications for Use" section focuses on treatment and modification of tissue rather than diagnosis or detection of medical conditions.
No
The device description clearly states it is a medical laser family equipped with hardware components (Alexandrite 755nm laser and Nd:YAG 1064nm laser sources, optical fiber, handpieces). While software verification and validation were performed, the device is fundamentally a hardware-based laser system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to treating conditions on the body (hair reduction, pigmented lesions, vascular lesions, wrinkles, scars). IVDs are used to diagnose conditions by examining samples taken from the body (like blood, urine, tissue).
- Device Description: The device is a laser system that delivers energy to the body. IVDs are typically instruments or reagents used to analyze samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is clearly a therapeutic laser system used for various dermatological and cosmetic procedures.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety and electromagnetic compatibility (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 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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DEKA Motus AZ (K211821)
Reference Device(s)
DEKA AGAIN PRO family (K233090)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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: 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"
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.
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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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.
4
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.
5
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.
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. .
6
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 hair | |||
| reduction through selective targeting of | ||||
| melanin in hair follicles. | Stable long-term or permanent hair | |||
| reduction through selective targeting of | ||||
| melanin in hair follicles. | Stable long-term or permanent hair | |||
| reduction through selective targeting of | ||||
| melanin in hair follicles. | Identical | |||
| 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. | 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 | ||||
| compilation of a treatment regime, on | ||||
| all skin types (Fitzpatrick I-VI) | ||||
| including tanned skin. | 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. | Treatment of benign pigmented lesions. | Treatment of benign pigmented lesions. | ||
| Photocoaugulation of benign | ||||
| dermatological vascular lesions (such as | ||||
| port-wine stains, hemangiomas, | ||||
| telangiectasias). | Photocoaugulation of benign | |||
| dermatological vascular lesions (such as | ||||
| port-wine stains, hemangiomas, | ||||
| telangiectasias). | Treatment of dermatological vascular | |||
| lesions (such as port-wine stains, | ||||
| hemangiomas, telangiectasias). | ||||
| Regulation number | 21 CFR 8784810: Laser surgical | |||
| instrument for use in general and plastic | ||||
| surgery and in dermatology | 21 CFR 8784810: Laser surgical | |||
| instrument for use in general and plastic | ||||
| surgery and in dermatology | 21 CFR 8784810: Laser surgical | |||
| instrument for use in general and plastic | ||||
| surgery 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/cm² | |||
| Moveo handpieces: 40 J/cm² | Stamp handpieces: 200 J/cm² | |||
| Moveo handpieces: 40 J/cm² | Stamp handpieces: 600 J/cm² | Identical to | ||
| reference for | ||||
| stamp | ||||
| handpieces. | ||||
| Identical to | ||||
| predicate for | ||||
| Moveo | ||||
| handpieces | ||||
| Handpiece Spot Sizes | ||||
| (diameter) | Stamp handpieces: | |||
| 2.5 mm | ||||
| 5 mm | ||||
| 7 mm | ||||
| 10 mm | ||||
| 12 mm | ||||
| 14 mm | ||||
| 15 mm | ||||
| 16 mm | ||||
| 18 mm | ||||
| 20 mm | ||||
| 22 mm | ||||
| 24 mm | ||||
| Moveo handpieces: | ||||
| 7 mm | ||||
| 14 mm | Stamp handpieces: | |||
| 2.5 mm | ||||
| 5 mm | ||||
| 7 mm | ||||
| 10 mm | ||||
| 12 mm | ||||
| 14 mm | ||||
| 15 mm | ||||
| 16 mm | ||||
| 18 mm | ||||
| 20 mm | ||||
| Moveo handpieces: | ||||
| 7 mm | ||||
| 14 mm | Stamp handpieces: | |||
| 2.5 mm | ||||
| 5 mm | ||||
| 7 mm | ||||
| 10 mm | ||||
| 12 mm | ||||
| 14 mm | ||||
| 15 mm | ||||
| 16 mm | ||||
| 18 mm | ||||
| 20 mm | ||||
| 24 mm | ||||
| 30 mm | Within the | |||
| range of | ||||
| reference | ||||
| device for | ||||
| stamp | ||||
| handpieces. | ||||
| Identical to | ||||
| predicate for | ||||
| Moveo | ||||
| handpieces. | ||||
| 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 to | ||
| reference | ||||
| Pulse Repetition Rate | Up to 12 Hz | Up to 10 Hz | Up to 12 Hz | Identical to |
| reference | ||||
| Skin Cooling System | Yes, optional | Yes, optional | Yes, optional | Identical |
| Skin Cooling Temperature | 15°C | 15°C | - | Identical to |
| predicate | ||||
| 1064 nm LASER (not available for Motus PRO AX) | ||||
| Indication 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. | ||||
| 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 | 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 | 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 hemostatis of | ||||
| pigmented and 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 | 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, 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 | 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 | macules, seborrheic keratosis, nevi, | |||
| cloasma, verrucae, skin tags, keratosis | ||||
| and plaques. | ||||
| 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 | ||||
| treatment. | ||||
| Reduction of red pigmentation in | ||||
| hypertrophic and keloid scars where | ||||
| vascularity is an integral part of the | ||||
| scar. | ||||
| Treatment of wrinkles. | ||||
| scar. | ||||
| Treatment of wrinkles. | scar. | |||
| Treatment of wrinkles. | ||||
| Regulation number | 21 CFR 8784810: Laser surgical | |||
| instrument for use in general and plastic | ||||
| surgery and in dermatology | 21 CFR 8784810: Laser surgical | |||
| instrument for use in general and plastic | ||||
| surgery and in dermatology | 21 CFR 8784810: Laser surgical | |||
| instrument for use in general and plastic | ||||
| surgery 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 to | ||
| predicate. | ||||
| 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 for | |
| stamp | ||||
| 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 to |
| reference | ||||
| Pulse Repetition Rate | Up to 12 Hz | Up to 10 Hz | Up to 12 Hz | Identical to |
| reference | ||||
| Skin Cooling System | Yes, optional | Yes, optional | Yes, optional | Identical |
| Skin Cooling Temperature | 15°C | 15°C | - | Identical to |
| predicate |
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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