DEKA LOTUS
Device Facts
| Record ID | K233473 |
|---|---|
| Device Name | DEKA LOTUS |
| Applicant | El.En S.P.A. |
| Product Code | ONF · General, Plastic Surgery |
| Decision Date | May 16, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
DEKA LOTUS is a multi-modality aesthetic system featuring two pulsed light handpieces and one RF handpiece. Pulsed light handpieces utilize a linear Xenon flashlamp to emit broad-spectrum electromagnetic radiation (590-1200nm or 500-670nm/870-1200nm) for hair removal and lesion treatment; handpieces include built-in cooled waveguides. RF handpiece delivers 1MHz bipolar electric current via electrodes to induce molecular oscillation and local tissue heating for wrinkle reduction. System operated by clinicians in dermatologic/surgical settings. Output parameters (fluence, pulse duration, power) are controlled by the user to achieve therapeutic thermal effects. Benefits include non-invasive skin rejuvenation and hair reduction.
Clinical Evidence
No clinical data provided. Substantial equivalence based on bench testing, including electrical safety (ANSI AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing per IEC 60601-2-57. Side-by-side electrical and thermal profile comparisons were conducted against the Pollogen Legend+ predicate.
Technological Characteristics
System includes two pulsed light handpieces (Xenon flashlamp, cooled waveguide) and one bipolar RF handpiece (1MHz, sinusoidal waveform). RF power delivery uses PWM modulation and phase rotation. Materials/specs: 15mm/6mm electrode diameters, 15mm/14mm electrode heights. Connectivity: main unit with flexible multifunctional cable. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57.
Indications for Use
Indicated for permanent hair removal (590nm handpiece); treatment of benign pigmented lesions (lentigines, nevi, melasma, cafe-au-lait) and benign vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, facial/leg veins) (500G handpiece); and non-invasive treatment of mild to moderate facial wrinkles and rhytides (RF handpiece).
Regulatory Classification
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
Predicate Devices
Submission Summary (Full Text)
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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.
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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).
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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
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# 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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### 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.
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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<br>Name | Proposed 510(k) Device<br>DEKA LOTUS | Predicate Device<br>K202503<br>QUANTA Chrome<br>IPL 590-1200 nm | Comments |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Indications for Use | Indicated for permanent hair<br>removal.<br>Permanent hair reduction is<br>defined as the long-term,<br>stable reduction in the number<br>of hairs regrowing when<br>measured at 6, 9, and 12<br>months after the completion of<br>a treatment regime. | Indicated for permanent hair<br>removal.<br>Permanent hair reduction is<br>defined as the long-term, stable<br>reduction in the number of hairs<br>regrowing when measured at 6,<br>9, and 12 months after the<br>completion of a treatment<br>regime. | Identical |
| Product code and<br>regulation | ONF<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 | Predicate device<br>includes laser<br>handpiece while the<br>subject device has<br>only IPL. |
| Pulsed light<br>Emission spectrum | 590 - 1200 nm | 590 - 1200 nm | Identical |
## 590nm Pulsed light handpiece
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| Device Trade<br>Name | Proposed 510(k) Device<br>DEKA LOTUS | Predicate Device<br>K202503<br>QUANTA Chrome<br>IPL 590-1200 nm | Comments |
|----------------------|--------------------------------------|------------------------------------------------------------------|----------------------------------------------------------|
| Fluence | Up to 25 J/cm² | Up to 25 J/cm² | Identical |
| Spot Size | 20x17 mm | 48x13 mm<br>25x13mm | Differences do not<br>affect safety and<br>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<br>Name | Proposed 510(k) Device | Predicate Device | Comments |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| DEKA LOTUS | Intended for treatment of benign<br>pigmented lesions, including<br>lentigines, nevi, melasma, and<br>cafe-au-lait; and treatment of<br>benign vascular lesions, including<br>port wine stains, hemangiomas,<br>angiomas, telangiectasias,<br>rosacea, facial and leg veins. | K110907<br>Palomar Icon<br>Max series Intense Pulsed light | |
| Indications for<br>Use | | The Max Series Intense Pulsed<br>Light Handpieces are intended for<br>the treatment of inflammatory<br>acne (acne vulgaris) and for the<br>treatment of benign pigmented<br>epidermal and cutaneous lesions,<br>including warts, scars and striae;<br>removal of unwanted hair from<br>skin types 1-VI, and to effect<br>stable long-term, or permanent,<br>hair reduction; treatment of<br>benign pigmented lesions,<br>including lentigines, nevi,<br>melasma, and cafe-au-lait; and<br>treatment of vascular lesions,<br>including port wine stains,<br>hemangiomas, angiomas,<br>telangiectasias, rosacea, facial<br>and leg veins. | Indications for use are<br>a subset of the ones<br>of the predicate<br>device. |
| Product code<br>and regulation | ONF<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 | Predicate device<br>includes laser<br>handpiece while the<br>subject device has<br>only IPL. |
| Pulsed light<br>Emission<br>spectrum | 500-670nm, 870-1200 nm | Max G handpiece:<br>500-670nm, 870-1200 nm | Identical |
| Fluence | Up to 80 J/cm² | Up to 80 J/cm² | Identical |
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| Device Trade Name | Proposed 510(k) Device | Predicate Device | Comments |
|-------------------|------------------------|------------------------------------------------------------|---------------------------------------------------------------------------|
| DEKA LOTUS | | K110907<br>Palomar Icon<br>Max series Intense Pulsed light | |
| Spot Size | 17x20 mm | 10x15 mm | Differences do not<br>affect safety and<br>effectiveness of the<br>device |
| Pulse Duration | 1-100 ms | 1-100 ms | Identical |
| Repetition Rate | 1 Hz max. | NA | NA |
### RF handpiece
| Device Trade<br>Name | Proposed 510(k) Device<br>DEKA LOTUS | Predicate Device<br>K173503<br>Pollogen Legend+™ System | Comments |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Intended for use in<br>dermatologic and general<br>surgical procedures for the non-<br>invasive treatment of mild to<br>moderate facial wrinkles and<br>rhytides | The Modified Pollogen<br>Legend+™ system is intended<br>for dermatological procedures<br>requiring ablation and<br>resurfacing of the skin when<br>using VoluDerm Energy<br>(Applicator VO).<br>It is also intended for use in<br>dermatologic and general<br>surgical procedures for the non-<br>invasive treatment of mild to<br>moderate facial wrinkles and<br>rhytides when using TriPollar RF<br>Energy (Applicators 1-3). | Indications for use are<br>a subset of the ones<br>of the predicate<br>device.<br>(No fractional Bipolar<br>RF applicator<br>available) |
| Product code and<br>regulation | GEI<br>21 CFR. 878.4400 | GEI<br>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<br>A1: bipolar RF, 6 electrodes,<br>VO: fractional bipolar RF | Subset (no fractional<br>bipolar RF or bipolar<br>RF with 6 electrodes<br>available). |
| Maximum output<br>power | 50W on 2000hm (large tip)<br>15W on 2000hm (medium tip) | 50W on 2000hm (applicatorA2)<br>15W on 2000hm (applicator A3) | Identical |
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| Device Trade<br>Name | Proposed 510(k) Device<br>DEKA LOTUS | Predicate Device<br>K173503<br>Pollogen Legend+™ System | Comments |
|----------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------|
| Output voltage on<br>200Ohm | 100V rms | 100V rms | Identical |
| Power delivery<br>algorithms | Power regulation by PWM<br>modulation, phase rotation<br>between electrodes | Power regulation by PWM<br>modulation, phase rotation<br>between electrodes | Identical |
| Electrodes<br>diameter | 15 mm (large tip)<br>6 mm (medium tip) | 15 mm (Applicator A2)<br>6 mm (Applicator A3) | Identical |
| Electrodes height | 15 mm (large tip)<br>14 mm (medium tip) | 15 mm (Applicator A2)<br>14 mm (Applicator A3) | Identical |
| Distance between<br>electrodes centers | 20 mm (large tip)<br>10 mm (medium tip) | 20 mm (Applicator A2)<br>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)
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### 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.
