· 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 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.

AI/ML Overview

This document is a 510(k) Summary for the DEKA LOTUS device, which is an intense pulsed light and radiofrequency (RF) system. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving specific performance metrics against pre-defined acceptance criteria for a novel AI/software component in a diagnostic context.

Therefore, the information required to answer your specific questions about acceptance criteria, ground truth, sample sizes for training/testing, expert adjudication, and MRMC studies is not present in this document. This is because the DEKA LOTUS is a medical device (pulsed light and RF system), and the 510(k) submission primarily relies on demonstrating equivalence to existing devices through non-clinical performance data (electrical safety, EMC) and comparisons of technical specifications and indications for use, rather than clinical performance studies involving AI algorithms.

Here's a breakdown of why this information is missing and what is provided:

Why the requested information is absent:

Nature of the Device: The DEKA LOTUS is a physical medical device (laser/light/RF system), not an AI/software-based diagnostic tool. Its performance is assessed through its physical characteristics and safety, not through diagnostic accuracy or interpretation of images/data by an algorithm.
510(k) Pathway: The 510(k) substantial equivalence pathway typically does not require extensive clinical trials or performance studies if the device is similar enough to existing ones. It focuses on comparing the new device to predicates in terms of indications for use, technological characteristics, and safety/EMC.
No AI/Software Component for Interpretation: There's no mention of a software component that interprets medical images, diagnoses conditions, or assists human readers in a diagnostic task. The software validation mentioned refers to the general control software for the device's operation, not an AI for diagnostic purposes.

What information is provided in the document (and how it relates to your questions, or why it doesn't):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the context of device performance metrics for an AI. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to the predicate devices through identical or similar technical specifications and parameters (e.g., fluence, pulse duration, frequency for light/RF) and demonstrating compliance with safety standards (IEC 60601 series).
- Reported Device Performance: The document provides comparative tables showing the technical specifications of the DEKA LOTUS against its predicate devices (Quanta Chrome, Palomar Icon, Pollogen Legend+™ System) for pulsed light (590nm, 500G) and RF handpieces. Examples include:
  - Pulsed Light (590nm): Fluence (Up to 25 J/cm² - identical to predicate), Spot Size (20x17 mm vs. predicates' 48x13 mm/25x13mm - difference noted as not affecting safety/effectiveness), Pulse Duration (Up to 40 ms - identical), Repetition Rate (3 Hz max. - identical).
  - Pulsed Light (500G): Fluence (Up to 80 J/cm² - identical), Spot Size (17x20 mm vs. predicate's 10x15 mm - difference noted as not affecting safety/effectiveness), Pulse Duration (1-100 ms - identical).
  - RF Handpiece: Frequency (1 MHz - identical), Waveform (Sinusoidal - identical), Maximum output power (50W or 15W - identical).
- Safety and EMC testing: The document states that electrical safety and electromagnetic compatibility (EMC) testing were conducted according to ANSI AAMI ES60601-1 and IEC 60601-1-2. There were also tests according to IEC 60601-2-57 for non-laser light source equipment. This implies these standards' requirements serve as "acceptance criteria" for basic safety and performance, which were met.
Sample sizes used for the test set and the data provenance: Not applicable. This refers to an AI/software's performance test set. The document mentions non-clinical testing (electrical safety, EMC, thermal profiles) but these don't involve test "samples" in the sense of patient data for a diagnostic algorithm. No clinical data or test sets are described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This relates to ground truth for diagnostic AI.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This relates to ground truth for diagnostic AI.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states "Clinical Performance Data: None." This type of study (MRMC) is relevant for assessing human reader performance with and without AI assistance, which is not the purpose of this submission for a light/RF device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no diagnostic algorithm to perform in a standalone manner.
The type of ground truth used: Not applicable. Ground truth typically refers to validated diagnostic labels for training/testing AI models.
The sample size for the training set: Not applicable. There is no AI model being trained on patient data.
How the ground truth for the training set was established: Not applicable. There is no AI model being trained on patient data.

In summary, this 510(k) submission for the DEKA LOTUS device demonstrates substantial equivalence based on the device's technical specifications and compliance with relevant safety and performance standards for physical medical devices, rather than a clinical performance study of an AI-powered diagnostic tool.

Summary

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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 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 TradeName	Proposed 510(k) DeviceDEKA LOTUS	Predicate DeviceK202503QUANTA ChromeIPL 590-1200 nm	Comments
Indications for Use	Indicated for permanent hairremoval.Permanent hair reduction isdefined as the long-term,stable reduction in the numberof hairs regrowing whenmeasured at 6, 9, and 12months after the completion ofa treatment regime.	Indicated for permanent hairremoval.Permanent hair reduction isdefined as the long-term, stablereduction in the number of hairsregrowing when measured at 6,9, and 12 months after thecompletion of a treatmentregime.	Identical
Product code andregulation	ONF21 CFR 878.4810	GEX21 CFR 878.4810	Predicate deviceincludes laserhandpiece while thesubject device hasonly IPL.
Pulsed lightEmission spectrum	590 - 1200 nm	590 - 1200 nm	Identical

590nm Pulsed light handpiece

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Device TradeName	Proposed 510(k) DeviceDEKA LOTUS	Predicate DeviceK202503QUANTA ChromeIPL 590-1200 nm	Comments
Fluence	Up to 25 J/cm²	Up to 25 J/cm²	Identical
Spot Size	20x17 mm	48x13 mm25x13mm	Differences do notaffect safety andeffectiveness
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 TradeName	Proposed 510(k) Device	Predicate Device	Comments
DEKA LOTUS	Intended for treatment of benignpigmented lesions, includinglentigines, nevi, melasma, andcafe-au-lait; and treatment ofbenign vascular lesions, includingport wine stains, hemangiomas,angiomas, telangiectasias,rosacea, facial and leg veins.	K110907Palomar IconMax series Intense Pulsed light
Indications forUse		The Max Series Intense PulsedLight Handpieces are intended forthe treatment of inflammatoryacne (acne vulgaris) and for thetreatment of benign pigmentedepidermal and cutaneous lesions,including warts, scars and striae;removal of unwanted hair fromskin types 1-VI, and to effectstable long-term, or permanent,hair reduction; treatment ofbenign pigmented lesions,including lentigines, nevi,melasma, and cafe-au-lait; andtreatment of vascular lesions,including port wine stains,hemangiomas, angiomas,telangiectasias, rosacea, facialand leg veins.	Indications for use area subset of the onesof the predicatedevice.
Product codeand regulation	ONF21 CFR 878.4810	GEX21 CFR 878.4810	Predicate deviceincludes laserhandpiece while thesubject device hasonly IPL.
Pulsed lightEmissionspectrum	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

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Device Trade Name	Proposed 510(k) Device	Predicate Device	Comments
DEKA LOTUS		K110907Palomar IconMax series Intense Pulsed light
Spot Size	17x20 mm	10x15 mm	Differences do notaffect safety andeffectiveness of thedevice
Pulse Duration	1-100 ms	1-100 ms	Identical
Repetition Rate	1 Hz max.	NA	NA

RF handpiece

Device TradeName	Proposed 510(k) DeviceDEKA LOTUS	Predicate DeviceK173503Pollogen Legend+™ System	Comments
Indications for Use	Intended for use indermatologic and generalsurgical procedures for the non-invasive treatment of mild tomoderate facial wrinkles andrhytides	The Modified PollogenLegend+™ system is intendedfor dermatological proceduresrequiring ablation andresurfacing of the skin whenusing VoluDerm Energy(Applicator VO).It is also intended for use indermatologic and generalsurgical procedures for the non-invasive treatment of mild tomoderate facial wrinkles andrhytides when using TriPollar RFEnergy (Applicators 1-3).	Indications for use area subset of the onesof the predicatedevice.(No fractional BipolarRF applicatoravailable)
Product code andregulation	GEI21 CFR. 878.4400	GEI21 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 electrodesA1: bipolar RF, 6 electrodes,VO: fractional bipolar RF	Subset (no fractionalbipolar RF or bipolarRF with 6 electrodesavailable).
Maximum outputpower	50W on 2000hm (large tip)15W on 2000hm (medium tip)	50W on 2000hm (applicatorA2)15W on 2000hm (applicator A3)	Identical

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Device TradeName	Proposed 510(k) DeviceDEKA LOTUS	Predicate DeviceK173503Pollogen Legend+™ System	Comments
Output voltage on200Ohm	100V rms	100V rms	Identical
Power deliveryalgorithms	Power regulation by PWMmodulation, phase rotationbetween electrodes	Power regulation by PWMmodulation, phase rotationbetween electrodes	Identical
Electrodesdiameter	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 betweenelectrodes 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)

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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.

Regulation Number and Section

§ 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.