(245 days)
Not Found
No
The summary describes a laser system for dermatological treatments and does not mention any AI or ML components in the device description or performance studies.
No.
A therapeutic device is typically used to treat a disease, injury, or other medical condition to alleviate symptoms or restore health. While the device treats some conditions like benign pigmented lesions, wrinkles, and vascular lesions, its primary stated use is for hair reduction and these other indications are aesthetic rather than addressing a disease state.
No
The device description and intended use indicate that the DEKA Motus AX laser system is used for various treatments (hair reduction, pigmented lesions, wrinkles, vascular lesions), not for diagnosing conditions.
No
The device description explicitly states it is a "medical device equipped with a 755nm solid state laser source" and includes physical components like an optical fiber, handpieces, and a footswitch/fingerswitch. This indicates it is a hardware-based device, not software-only.
Based on the provided information, the DEKA Motus AX laser system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended uses listed are all related to treating conditions on the human body (hair reduction, pigmented lesions, wrinkles, vascular lesions). IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laser system that delivers energy to the body. It does not describe a device that analyzes biological samples.
- Lack of IVD-specific information: The document does not mention any processes related to sample collection, preparation, or analysis of biological specimens, which are core to IVD devices.
Therefore, the DEKA Motus AX is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The DEKA Motus AX laser system is indicated for:
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).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The DEKA Motus AX is a medical device equipped with a 755nm solid state laser source. The laser source delivers 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. Handpiece activation is either by footswitch or fingerswitch.
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
Prescription Use
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)
Clinical Performance Data:
None
Non-Clinical Performance Data:
The DEKA Motus AX was tested for standards conformance with the following standards:
IEC 60601-1- Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - Requirements and tests.
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.
Moreover, ex-vivo performance data on three different tissue types were submitted in order to show that DEKA Motus AX produces comparable thermal energy distribution and adversely affected tissue region as the predicate for the range of energy deposition parameters from the subject and predicate devices for the worst-case deposition time.
Finally, biocompatibility tests have been performed on the Moveo handpiece tip, which comes in contact with the patient.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
DEKA Synchro Repla: Y family of laser systems (K150516).
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is composed of three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2017
El.En. Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 50041 Calenzano (FI), Italy
Re: K162886
Trade/Device Name: DEKA Motus AX 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 15, 2017 Received: May 18, 2017
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. 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.
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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162886
Device Name DEKA Motus AX
Indications for Use (Describe)
The DEKA Motus AX laser system is indicated for:
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).
| 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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3
510(K) Summary DEKA Motus AX
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 19th, 2017
Device Trade Name:
DEKA Motus AX
Common Name:
Medical Laser system
Classification Name:
Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology (GEX)
Classification Number:
21 CFR 878.4810
Predicate Devices:
DEKA Synchro Repla: Y family of laser systems (K150516).
Device Description:
The DEKA Motus AX is a medical device equipped with a 755nm solid state laser source. The laser source delivers 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. Handpiece activation is either by footswitch or fingerswitch.
Intended 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.
4
Treatment of wrinkles. Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Substantial equivalence discussion:
The DEKA Motus AX is substantially equivalent to the 755nm laser source of the DEKA Synchro Repla: Y family of laser systems (K150516).
| Device Trade
Name | DEKA Motus AX | Predicate Device
K150516
DEKA Synchro Repla: Y family of
laser systems
(755nm laser source) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Laser Type | Alexandrite | Alexandrite |
| Wavelength | 755 nm | 755 nm |
| Max Fluence | 2.5mm handpicece: 600J/cm2
5mm handpicece: 160J/cm2
7mm handpicece: 80J/cm2
10mm handpicece: 40J/cm2
12mm handpicece: 27J/cm2
14mm handpicece: 20J/cm2
15mm handpicece: 17J/cm2
16mm handpicece: 15J/cm2
18mm handpicece: 12J/cm2
20mm handpicece: 10J/cm2
Mõveõ handpicece:8J/cm2 | 2.5mm handpicece: 600J/cm2
5mm handpicece: 160J/cm2
7mm handpicece: 80J/cm2
10mm handpicece: 40J/cm2
12mm handpicece: 27J/cm2
14mm handpicece: 20J/cm2
15mm handpicece: 17J/cm2
16mm handpicece: 15J/cm2
18mm handpicece: 12J/cm2
20mm handpicece: 10J/cm2
22mm handpicece: 16J/cm2
24mm handpicece: 14J/cm2 |
| Spot Sizes | 2.5 to 20mm | 2.5 to 24mm |
| Pulse Duration | 0.25 to 300 ms | 0.25 to 300 ms |
| Pulse Rep Rate | up to 10 Hz | up to 10 Hz |
| Skin Cooling
System | Yes, integrated in the Moveo
handpiece, external optional for the
other handpieces | Yes, optional, integrated by
Smartcooler handpiece or external. |
The DEKA Motus AX has the same indications for use as the above mentioned predicate device, with same principle of operation and essentially the same performances.
Clinical Performance Data:
None
Non-Clinical Performance Data:
The DEKA Motus AX was tested for standards conformance with the following standards:
IEC 60601-1- Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
5
IEC 60601-1-2 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - Requirements and tests.
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.
Moreover, ex-vivo performance data on three different tissue types were submitted in order to show that DEKA Motus AX produces comparable thermal energy distribution and adversely affected tissue region as the predicate for the range of energy deposition parameters from the subject and predicate devices for the worst-case deposition time.
Finally, biocompatibility tests have been performed on the Moveo handpiece tip, which comes in contact with the patient.
Conclusion:
Based on the outcome of non-clinical performance data performed, we can conclude that the DEKA Motus AX laser system is substantially equivalent to the predicate device .
Additional Information:
None