(204 days)
No
The device description and performance studies focus on pulsed light and RF technology, with no mention of AI or ML.
Yes
The device is indicated for permanent hair removal, treatment of benign pigmented lesions, benign vascular lesions, and facial wrinkles and rhytides, all of which address medical conditions or modify the structure/function of the body.
No
The DEKA LOTUS device is described as being used for permanent hair removal, treatment of benign pigmented and vascular lesions, and treatment of mild to moderate facial wrinkles and rhytides, which are all therapeutic or cosmetic procedures, not diagnostic ones.
No
The device description explicitly states it is provided with two pulsed light handpieces and an RF handpiece, which are hardware components. The performance studies also mention electrical safety and EMC testing, which are relevant to hardware.
Based on the provided information, the DEKA LOTUS device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended uses described are for treatment of various conditions (hair removal, pigmented lesions, vascular lesions, wrinkles). IVDs are used to diagnose or aid in the diagnosis of diseases or conditions by examining specimens taken from the human body (like blood, urine, tissue).
- Device Description: The device uses pulsed light and radiofrequency energy to directly interact with the body's tissues for therapeutic purposes. This is characteristic of a therapeutic device, not a diagnostic one.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens.
Therefore, the DEKA LOTUS falls under the category of a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The DEKA LOTUS 590nm pulsed light handpiece is indicated for permanent hair removal. 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.
The DEKA LOTUS 500G pulsed light handpiece is intended for treatment of benion pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of benign vascular lesions, including port wine stains, hemangiomas, telangiectasias, rosacea, facial and leg veins.
The DEKA LOTUS RF handpiece is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
Product codes (comma separated list FDA assigned to the subject device)
ONF, GEI
Device Description
The DEKA Lotus is a device provided with two pulsed light handpieces and a RF handpiece.
The two pulsed light handpieces have a built-in cooled waveguide which differ in emission spectrum, connected to the main unit through a flexible multifunctional cable.
The handpiece uses a linear Xenon flashlamp, emitting a broad spectrum of electromagnetic radiation (light) when energized.
The RF handpiece produces a particular electric current at 1MHz that induces a molecular oscillation on the cells, raising their temperature locally. The RF current flows through the special electrodes, forming a homogeneous heat area.
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)
Clinical Performance Data: None.
Non-Clinical Performance Data:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the PHYSIQ 360 device, according to the following standards:
. ANSI AAMI ES60601-1: 2005 / A1: 2012 / A2: 2020: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
. IEC 60601-1-2: 2014 / A1: 2020: 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, "Content of Premarket Submissions for Device Software Functions". Additional non-clinical testing conducted.
Additional tests were conducted on the LOTUS device:
. Test according to IEC 60601-2-57 Edition 1.0 2011-01: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
- Test according to the standard IEC 60601-2-57 Edition 1.0 2011-01:
- side-by-side electrical comparison between RF handpiece and predicate device (K173503)
- side-by-side thermal profile comparison between RF handpiece and predicate device (K173503)
Conclusion:
Based on the comparison of indications for use and the technological characteristics, we can conclude that the DEKA LOTUS device is as safe, as effective, and performs as well as the legally marketed predicate devices K202503, K110907 and K173503.
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 16, 2024
El.EN S.p.A. Paolo Peruzzi Regulatory Affairs Manager via Baldanzese 17 Calenzano, F1 50041 Italy
Re: K233473
Trade/Device Name: Deka Lotus 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: ONF, GEI Dated: April 18, 2024 Received: April 18, 2024
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 (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/cdrb/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
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" (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 QS 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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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,
Tanisha L. Digitally signed by Hithe -S_ Date: 2024.05.16 12:27:47 -04'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & Infection Control Devices, Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
K233473
Device Name
DEKA LOTUS
Indications for Use (Describe)
· The DEKA LOTUS 590nm pulsed light handpiece is indicated for permanent hair removal. 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.
· The DEKA LOTUS 500G pulsed light handpiece is intended for treatment of benion pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of benign vascular lesions, including port wine stains, hemangiomas, telangiectasias, rosacea, facial and leg veins.
· The DEKA LOTUS RF handpiece is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
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)
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4
510(k) Summary # K233473
DEKA LOTUS
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:
April 18, 2024
Device Trade Name:
DEKA LOTUS
Common Name:
Medical Intense Pulsed Light and RF system.
Regulation Name:
Powered light-based non-laser surgical instrument with thermal effect, Electrosurgical cutting and coagulation device and accessories.
Product Code:
ONF, GEI
Regulatory Class:
Class II
Regulation Number:
21 CFR 878.4810 21 CFR. 878.4400
Predicate Devices:
Quanta Chrome (K202503) Palomar Icon (K110907) Pollogen Legend+™ System (K173503)
Device Description:
The DEKA Lotus is a device provided with two pulsed light handpieces and a RF handpiece.
5
The two pulsed light handpieces have a built-in cooled waveguide which differ in emission spectrum, connected to the main unit through a flexible multifunctional cable.
The handpiece uses a linear Xenon flashlamp, emitting a broad spectrum of electromagnetic radiation (light) when energized.
The RF handpiece produces a particular electric current at 1MHz that induces a molecular oscillation on the cells, raising their temperature locally. The RF current flows through the special electrodes, forming a homogeneous heat area.
Indications for Use:
The DEKA LOTUS 590 nm Pulsed Light handpiece is indicated for permanent hair removal. 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.
The DEKA LOTUS 500G Pulsed Light handpiece is intended for treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of benign vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
The DEKA LOTUS RF handpiece is intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
Comparison with The Predicate Device:
The DEKA LOTUS is substantially equivalent to Quanta Chrome (K202503), Palomar Icon (K110907) AND Pollogen Legend+™ System (K173503):
| Device Trade
Name | Proposed 510(k) Device
DEKA LOTUS | Predicate Device
K202503
QUANTA Chrome
IPL 590-1200 nm | Comments |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Indications for Use | Indicated for permanent hair
removal.
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. | Indicated for permanent hair
removal.
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. | Identical |
| Product code and
regulation | ONF
21 CFR 878.4810 | GEX
21 CFR 878.4810 | Predicate device
includes laser
handpiece while the
subject device has
only IPL. |
| Pulsed light
Emission spectrum | 590 - 1200 nm | 590 - 1200 nm | Identical |
590nm Pulsed light handpiece
6
| Device Trade
Name | Proposed 510(k) Device
DEKA LOTUS | Predicate Device
K202503
QUANTA Chrome
IPL 590-1200 nm | Comments |
|----------------------|--------------------------------------|------------------------------------------------------------------|----------------------------------------------------------|
| Fluence | Up to 25 J/cm² | Up to 25 J/cm² | Identical |
| Spot Size | 20x17 mm | 48x13 mm
25x13mm | Differences do not
affect safety and
effectiveness |
| Pulse Duration | Up to 40 ms | Up to 40 ms | Identical |
| Repetition Rate | 3 Hz max. | 3 Hz max. | Identical |
500G Pulsed light handpiece
| Device Trade
| Name | Proposed 510(k) Device | Predicate Device | Comments |
|---|---|---|---|
| DEKA LOTUS | Intended for treatment of benign | ||
| pigmented lesions, including | |||
| lentigines, nevi, melasma, and | |||
| cafe-au-lait; and treatment of | |||
| benign vascular lesions, including | |||
| port wine stains, hemangiomas, | |||
| angiomas, telangiectasias, | |||
| rosacea, facial and leg veins. | K110907 | ||
| Palomar Icon | |||
| Max series Intense Pulsed light | |||
| Indications for | |||
| Use | The Max Series Intense Pulsed | ||
| Light Handpieces are intended for | |||
| the treatment of inflammatory | |||
| acne (acne vulgaris) and for the | |||
| treatment of benign pigmented | |||
| epidermal and cutaneous lesions, | |||
| including warts, scars and striae; | |||
| removal of unwanted hair from | |||
| skin types 1-VI, and to effect | |||
| stable long-term, or permanent, | |||
| hair reduction; treatment of | |||
| benign pigmented lesions, | |||
| including lentigines, nevi, | |||
| melasma, and cafe-au-lait; and | |||
| treatment of vascular lesions, | |||
| including port wine stains, | |||
| hemangiomas, angiomas, | |||
| telangiectasias, rosacea, facial | |||
| and leg veins. | Indications for use are | ||
| a subset of the ones | |||
| of the predicate | |||
| device. | |||
| Product code | |||
| and regulation | ONF | ||
| 21 CFR 878.4810 | GEX | ||
| 21 CFR 878.4810 | Predicate device | ||
| includes laser | |||
| handpiece while the | |||
| subject device has | |||
| only IPL. | |||
| Pulsed light | |||
| Emission | |||
| spectrum | 500-670nm, 870-1200 nm | Max G handpiece: | |
| 500-670nm, 870-1200 nm | Identical | ||
| Fluence | Up to 80 J/cm² | Up to 80 J/cm² | Identical |
7
| Device Trade Name | Proposed 510(k) Device | Predicate Device | Comments |
|---|---|---|---|
| DEKA LOTUS | K110907 | ||
| Palomar Icon | |||
| Max series Intense Pulsed light | |||
| Spot Size | 17x20 mm | 10x15 mm | Differences do not |
| affect safety and | |||
| effectiveness of the | |||
| device | |||
| Pulse Duration | 1-100 ms | 1-100 ms | Identical |
| Repetition Rate | 1 Hz max. | NA | NA |
RF handpiece
| Device Trade
Name | Proposed 510(k) Device
DEKA LOTUS | Predicate Device
K173503
Pollogen Legend+™ System | Comments |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Intended for use in
dermatologic and general
surgical procedures for the non-
invasive treatment of mild to
moderate facial wrinkles and
rhytides | The Modified Pollogen
Legend+™ system is intended
for dermatological procedures
requiring ablation and
resurfacing of the skin when
using VoluDerm Energy
(Applicator VO).
It is also intended for use in
dermatologic and general
surgical procedures for the non-
invasive treatment of mild to
moderate facial wrinkles and
rhytides when using TriPollar RF
Energy (Applicators 1-3). | Indications for use are
a subset of the ones
of the predicate
device.
(No fractional Bipolar
RF applicator
available) |
| Product code and
regulation | GEI
21 CFR. 878.4400 | GEI
21 CFR 878.4400 | Identical |
| Energy source | RF (bipolar) | RF (bipolar) | Identical |
| Frequency | 1 MHz | 1 MHz | Identical |
| Waveform | Sinusoidal | Sinusoidal | Identical |
| Applicator type | Bipolar RF, 3 electrodes | A2, A3: bipolar RF, 3 electrodes
A1: bipolar RF, 6 electrodes,
VO: fractional bipolar RF | Subset (no fractional
bipolar RF or bipolar
RF with 6 electrodes
available). |
| Maximum output
power | 50W on 2000hm (large tip)
15W on 2000hm (medium tip) | 50W on 2000hm (applicatorA2)
15W on 2000hm (applicator A3) | Identical |
8
| Device Trade
Name | Proposed 510(k) Device
DEKA LOTUS | Predicate Device
K173503
Pollogen Legend+™ System | Comments |
|----------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------|
| Output voltage on
200Ohm | 100V rms | 100V rms | Identical |
| Power delivery
algorithms | Power regulation by PWM
modulation, phase rotation
between electrodes | Power regulation by PWM
modulation, phase rotation
between electrodes | Identical |
| Electrodes
diameter | 15 mm (large tip)
6 mm (medium tip) | 15 mm (Applicator A2)
6 mm (Applicator A3) | Identical |
| Electrodes height | 15 mm (large tip)
14 mm (medium tip) | 15 mm (Applicator A2)
14 mm (Applicator A3) | Identical |
| Distance between
electrodes centers | 20 mm (large tip)
10 mm (medium tip) | 20 mm (Applicator A2)
10 mm (Applicator A3) | Identical |
Clinical Performance Data:
None.
Non-Clinical Performance Data:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the PHYSIQ 360 device, according to the following standards:
. ANSI AAMI ES60601-1: 2005 / A1: 2012 / A2: 2020: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
. IEC 60601-1-2: 2014 / A1: 2020: 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, "Content of Premarket Submissions for Device Software
Functions". Additional non-clinical testing conducted.
Additional tests were conducted on the LOTUS device:
. Test according to IEC 60601-2-57 Edition 1.0 2011-01: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
-
Test according to the standard IEC 60601-2-57 Edition 1.0 2011-01:
-
side-by-side electrical comparison between RF handpiece and predicate device (K173503)
-
side-by-side thermal profile comparison between RF handpiece and predicate device (K173503)
9
Conclusion:
Based on the comparison of indications for use and the technological characteristics, we can conclude that the DEKA LOTUS device is as safe, as effective, and performs as well as the legally marketed predicate devices K202503, K110907 and K173503.
Additional Information:
None.