(25 days)
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.
Motus AZ is a medical device equipped with Alexandrite 755nm 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 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.
This document is a 510(k) summary for the DEKA Motus AZ device, a laser surgical instrument. It primarily focuses on demonstrating substantial equivalence to a predicate device (DEKA Motus AY, K181486) rather than providing extensive details about a specific clinical study for performance acceptance criteria.
The acceptance criteria presented are essentially that the proposed device (DEKA Motus AZ) maintains the same or equivalent specifications and performance characteristics as the predicate device (DEKA Motus AY). The submission asserts that the modifications are minor and do not affect safety or effectiveness.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for clinical efficacy or specific performance metrics in the way one might expect from a clinical trial summary. Instead, the acceptance criteria are implicitly met by demonstrating that the DEKA Motus AZ's specifications and performance are identical to or within acceptable variations of the predicate device (DEKA Motus AY).
| Characteristic | Acceptance Criterion (Predicate Device DEKA MOTUS AY, K181486) | Reported Device Performance (Proposed Device DEKA Motus AZ) | Comment |
|---|---|---|---|
| General Specifications | |||
| Weight | Approx. 90 kg | Approx. 100 kg | The variation to the weight does not affect safety and effectiveness of the device. |
| Dimensions (cm) | 95x51x83 (HxWxD) | 114x45x94 (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 |
| Indications for Use (Alexandrite 755nm) | Temporary hair reduction; Stable long-term or permanent hair reduction on all skin types (Fitzpatrick I - VI) including tanned skin; Treatment of benign pigmented lesions; Treatment of wrinkles; Photocoagulation of benign dermatological vascular lesions. | Identical | Identical |
| Indications for Use (Nd:YAG 1064nm) | Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB on all Skin Types Fitzpatrick I-VI including tanned skin; Photocoagulation and hemostasis of benign pigmented and benign vascular lesions; Coagulation and hemostasis of soft tissue; Benign pigmented lesions (various types); Reduction of red pigmentation in hypertrophic and keloid scars; Treatment of wrinkles. | Identical | Identical |
| Regulation number | 21 CFR 878.4810: Laser surgical instrument for use in general and plastic surgery and in dermatology | Identical | Identical |
| Product Code | GEX | Identical | Identical |
| Alexandrite 755nm Laser Source | |||
| 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 mm) | 2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 14 mm) | 2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 7, 14 mm) | Identical overall spot size range (note: new Moveo spot size available, but within 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 |
| Nd:YAG 1064nm Laser Source | |||
| 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 |
| Handpiece Spot Sizes (diameter mm) | 2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 14 mm) | 2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 5, 14 mm) | Identical overall spot size range (note: new Moveo spot size available, but within 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 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on demonstrating substantial equivalence to a predicate device through engineering and performance comparisons, not on a prospective clinical trial with a "test set" as one might find for a novel device or AI algorithm. It's a "Special 510(k)" which generally indicates modifications to an already cleared device.
Therefore, there is no mention of a specific clinical "test set" sample size or data provenance in the context of efficacy for the modified DEKA Motus AZ device. The "data" refers to engineering and non-clinical performance data.
3. 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 applicable. This submission is for a laser surgical instrument, and the performance testing mentioned (electrical safety, EMC, software validation) does not involve establishing ground truth by medical experts for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See #3.
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
Not applicable. This is a laser surgical instrument, not an AI-based diagnostic tool that would typically involve MRMC studies or human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. See #5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of clinical efficacy ground truth for a test set. The "ground truth" for this submission are the established safety and performance standards for laser medical devices and the characteristics of the predicate device.
8. The sample size for the training set
Not applicable. This document does not describe the development or testing of an AI algorithm with a training set.
9. How the ground truth for the training set was established
Not applicable. See #8.
Summary of the Study Proving Acceptance Criteria:
The "study" proving the device meets its acceptance criteria, in this context, is the demonstration of substantial equivalence to the predicate device (DEKA Motus AY, K181486) through a combination of:
- Non-clinical performance testing:
- Electrical safety and electromagnetic compatibility (EMC): Conducted according to ANSI AAMI ES60601-1 and IEC 60601-1-2 standards.
- Software Validation and Verification Testing: 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 according to IEC 60601-2-22 (particular requirements for laser equipment) and IEC 60825-1 (safety of laser products).
- Comparison of technological characteristics: A detailed side-by-side comparison (as shown in the provided table) confirming that the proposed device (DEKA Motus AZ) shares the same intended use, fundamental technology (Alexandrite 755nm and Nd:YAG 1064nm lasers, wavelengths, fluences, pulse durations, repetition rates, skin cooling systems), and similar or identical essential design parameters within acceptable ranges as the predicate device. The changes (restyling, new Moveo handpiece spot sizes and optional spacer) were evaluated to ensure they do not introduce new questions of safety or effectiveness.
The conclusion states: "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)." This statement serves as the proof that the device meets the implicit acceptance criteria of being substantially equivalent to the cleared predicate.
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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: 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.
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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
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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)
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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.
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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 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 DeviceDEKA Motus AZ | Predicate DeviceDEKA MOTUS AY(K181486) | Comment |
|---|---|---|---|
| Weight | Approx. 100 kg | Approx. 90 kg | The variation to the weight doesnot affect safety andeffectiveness of the device |
| Dimensions (cm) | 114x45x94 (HxWxD) | 95x51x83 (HxWxD) | The variation to the dimensionsdoes not affect safety andeffectiveness 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 |
| Operatingenvironmentalconditions | 15-35 °C; 30%-75% rel. humidity, 700-1060 hPa | 15-35 °C; 30%-75% rel. humidity, 700-1060 hPa | Identical |
| Transport andstorage conditions | 5-50 °C; 10-90% humidity, 700-1060 hPa | 5-50 °C; 10-90% humidity, 700-1060 hPa | Identical |
| Device Trade Name | Proposed DeviceDEKA Motus AZ | Predicate DeviceDEKA MOTUS AY(K181486) | Comment |
| Indications for Use | Temporary hair reduction.Stable long-term or permanent hair reductionthrough selective targeting of melanin in hairfollicles. Permanent hair reduction is defined asthe long-term, stable reduction in the number ofhairs regrowing when measured at 6,9, and 12months after the completion of a treatmentregime, on all skin types (Fitzpatrick I - VI)including tanned skin.Treatment of benign pigmented lesions.Treatment of wrinkles.Photocoagulation of benign dermatologicalvascular lesions (such as port-wine stains,hemangiomas, telangiectasias). | Temporary hair reduction.Stable long-term or permanent hair reductionthrough selective targeting of melanin in hairfollicles. Permanent hair reduction is defined asthe long-term, stable reduction in the number ofhairs regrowing when measured at 6,9, and 12months after the completion of a treatmentregime, on all skin types (Fitzpatrick I - VI)including tanned skin.Treatment of benign pigmented lesions.Treatment of wrinkles.Photocoagulation of benign dermatologicalvascular lesions (such as port-wine stains,hemangiomas, telangiectasias). | Identical |
| Regulation number | 21 CFR 878.4810: Laser surgical instrument for usein general and plastic surgery and in dermatology | 21 CFR 878.4810: Laser surgical instrument for usein general and plastic surgery and in dermatology | Identical |
| Product Code | GEX | GEX | Identical |
| Device Trade Name | Proposed DeviceDEKA Motus AZ | Predicate DeviceDEKA 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 SpotSizes(diametermillimeter) | 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 spotsize range |
| Pulse Duration(milliseconds) | 2 to 50 ms | 2 to 50 ms | Identical |
| Pulse RepetitionRate (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 CoolingTemperature | 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 havenot responded to other laser treatments. | treatment, and for patients with lesions that havenot responded to other laser treatments. | ||
| The laser is also indicated for the reduction of redpigmentation in hypertrophic and keloid scarswhere vascularity is an integral part of the scar.Treatment of wrinkles. | The laser is also indicated for the reduction of redpigmentation in hypertrophic and keloid scarswhere vascularity is an integral part of the scar.Treatment of wrinkles. | ||
| Regulation number | 21 CFR 878.4810: Laser surgical instrument for usein general and plastic surgery and in dermatology | 21 CFR 878.4810: Laser surgical instrument for usein 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 SpotSizes(diametermillimeter) | 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 spotsize range |
| Pulse Duration(milliseconds) | 0.2 to 50 ms | 0.2 to 50 ms | Identical |
| Pulse RepetitionRate (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 CoolingTemperature | 15°C | 15°C | Identical |
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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.
§ 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.