Who is the manufacturer of DEKA AGAIN PRO family?

El.En S.P.A. filed the 510(k) submission for DEKA AGAIN PRO family (K233090).

What is the FDA product code for DEKA AGAIN PRO family?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for DEKA AGAIN PRO family?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like DEKA AGAIN PRO family?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DEKA AGAIN PRO family

Q: What are the predicate devices for DEKA AGAIN PRO family?

DEKA SYNCHRO REPLA:Y family of Laser system (K150516).

K233090 · El.En S.P.A. · GEX · Oct 27, 2023 · General, Plastic Surgery

Device Facts

Record ID	K233090
Device Name	DEKA AGAIN PRO family
Applicant	El.En S.P.A.
Product Code	GEX · General, Plastic Surgery
Decision Date	Oct 27, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The DEKA AGAIN PRO family is a medical laser family intended for: Alexandrite laser (755nm): - 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) included tanned skin. - Treatment of benign pigmented lesions. - Treatment of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). Nd:YAG laser (1064nm): - Removal of unwanted hair for stable long term or permanent hair reduction and for treatment of PFB. The laser are indicated on all Skin Types Fitzapatrick I-VI including tanned skin. - Photocoaqulation and hemostasis of pigmented and 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 od soft tissue. - Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (such spots), cafè au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. - 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. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Treatment of wrinkles.

Device Story

Medical laser system utilizing Alexandrite (755nm) and Nd:YAG (1064nm) sources; delivers energy via lens-coupled, user-replaceable optical fibers with interchangeable handpieces featuring electronic spot recognition. Used in clinical settings by trained professionals for dermatological procedures including hair reduction, vascular/pigmented lesion treatment, and soft tissue coagulation. Device features include optional skin cooling system. Modifications from predicate include updated chassis, GUI, and expanded spot size ranges. Output is controlled by the operator to achieve photocoagulation or photothermolysis based on clinical indication. Benefits include precise targeting of melanin or vascular structures to achieve therapeutic outcomes in skin conditions and hair removal.

Clinical Evidence

Bench testing only. Includes electrical safety (AAMI/ANSI ES60601-1, IEC 60601-2-22), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), and software verification/validation per FDA guidance.

Technological Characteristics

Medical laser system; Alexandrite (755nm) and Nd:YAG (1064nm) sources; max fluence 600 J/cm²; spot sizes 2.5-30mm; pulse duration 0.2-300ms; repetition rate up to 12Hz; optional skin cooling; electronic spot recognition handpieces; software-controlled GUI.

Indications for Use

Indicated for temporary or permanent hair reduction (all Fitzpatrick skin types I-VI, including tanned), treatment of benign pigmented lesions, dermatological vascular lesions (e.g., port-wine stains, hemangiomas, telangiectasias), PFB, soft tissue coagulation/hemostasis, hypertrophic/keloid scar red pigmentation reduction, and wrinkle treatment.

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

DEKA SYNCHRO REPLA:Y family of Laser system (K150516)

Related Devices

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 27, 2023 El. En. S.p.A. Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, Fl 50141 Italy Re: K233090 Trade/Device Name: DEKA AGAIN PRO family 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: September 26, 2023 Received: September 26, 2023 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 (the 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/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. {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 (OS) 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. Hithe -S Tanisha L. 2023.10.27 Hithe -S 00:30:55 -04'00' Tanisha Hithe 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 {3}------------------------------------------------ ## Indications for Use Submission Number (if known) #### K233090 Device Name DEKA AGAIN PRO family Indications for Use (Describe) The DEKA AGAIN PRO family is a medical laser family intended for: Alexandrite laser (755nm): - 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) included tanned skin. - Treatment of benign pigmented lesions. - Treatment of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). Nd:YAG laser (1064nm): - Removal of unwanted hair for stable long term or permanent hair reduction and for treatment of PFB. The laser are indicated on all Skin Types Fitzapatrick I-VI including tanned skin. - Photocoaqulation and hemostasis of pigmented and 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 od soft tissue. - Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (such spots), cafè au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. - 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. - 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) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {4}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ #### 510(k) Summary #### K233090 #### AGAIN PRO family – 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: October 20, 2023 Device Trade Name: DEKA AGAIN PRO ### Manufacturer: DEKA M.E.L.A. srl Via Baldanzese, 17 50041 Calenzano (FI), Italy #### Common Name: Medical laser system # Regulation Number: 21 CFR 878.4810 ### Regulation Name: Laser Surgical Instrument for use in General and Plastic and in Dermatology #### Regulatory Class: Class II ### Product Code: GEX {6}------------------------------------------------ ## Predicate Devices: DEKA SYNCHRO REPLA:Y family of Laser system (K150516) ### Device Description: The DEKA AGAIN PRO family is a medical laser family 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 wider range of interchangeable, quick release laser handpieces with electronic spot recognition. The modifications to the device consist in a restyling of the device (new chassis, cover plastic, dimensions, weight and GUI, removal of Pulsed Light FT handpiece) and in modification to spot size ranges (new spot size available). The intended use of the modified device, 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. ### Intended Use: The DEKA AGAIN PRO family is intended for: ### - 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 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 laser is indicated on all Skin Types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemastatis of pigmented and 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. {7}------------------------------------------------ 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 pigmented lesions to reduce lesion size, or 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 in an integral part of the scar. Treatment of wrinkles. {8}------------------------------------------------ # Substantial equivalence discussion: | Device Trade Name | Subject Device | Predicate Device | Comment | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | | AGAIN PRO family | K150516 SYNCHRO REPLA:Y | | | Indications for use | Alexandrite 755 nm laser: 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. Treatment of benign pigmented lesions. Treatment of wrinkles. Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). Nd:YAG 1064 nm laser: 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 pigmented and 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), café au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. The laser is indicated for pigmented lesions to reduce lesion | Alexandrite 755 nm laser: 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. Treatment of benign pigmented lesions. Treatment of wrinkles. Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). Nd:YAG 1064 nm laser: 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 pigmented and 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), café au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. | Identical for 755nm laser and 1064nm laser; Pulsed light FT handpiece is not available for Again Pro Family | {9}------------------------------------------------ | Device Trade Name | Subject Device AGAIN PRO family | Predicate Device K150516 SYNCHRO REPLA:Y | Comment | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--| | | size, or 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. | The laser is indicated for pigmented lesions to reduce lesion size, or 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. Pulsed light FT handpiece: Permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions. Different wavelength ranges of pulsed light attachment are indicated for the various treatments and skin types, as indicated in the following table: Pulsed light wavelength range Hair reduction Vascular lesions Blood vessels Pigmented lesions 500 - 1200 nm - Skin Types I, II Skin Types I, II - 520 - 1200 nm - Skin Type III Skin Type III Skin Types I, II 550 - 1200 nm Skin Types I, II - - Skin Type III 600 – 1200 nm Skin Type III - - - 650 – 1200 nm Skin Type IV - - Skin Type IV | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 755 nm LASER (not available for SYMPHONY) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Laser Type | Alexandrite | Alexandrite | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Wavelength (nm) | 755nm | 755 nm | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | {10}------------------------------------------------ | Device Trade Name | Subject Device AGAIN PRO family | Predicate Device K150516 SYNCHRO REPLA:Y | Comment | |-----------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | Max Fluence (J/cm²) * | 600 (J/cm²) | 600 (J/cm²) | Identical | | Handpiece Spot Sizes (diameter millimeter) | 2.5 mm 5 mm 7 mm 10 mm 12 mm 14 mm 15 mm 16 mm 18 mm 20 mm 22 mm 24 mm 30 mm | 2.5 mm 5 mm 7 mm 10 mm 12 mm 14 mm 15 mm 16 mm 18 mm 20 mm 22 mm 24 mm | Almost identical, different maximum spot size but same fluence range. Change do not affect safety and effectiveness of the device | | Pulse Duration (milliseconds) | 0.2 to 300 ms | 0.25 to 300 ms | Almost identical, minimum pulse duration is slightly different. Change do not affect safety and effectiveness of the device | | Pulse Repetition Rate | Up to 12 Hz | Up to 10 Hz | Similar, maximum frequency is slightly | | Device Trade Name | Subject Device AGAIN PRO family | Predicate Device K150516 SYNCHRO REPLA:Y | Comment | | | | | Change do not affect safety and effectiveness of the device | | Skin Cooling System | Yes, optional | Yes, optional | Identical | | 1064 nm LASER | | | | | Laser Type | Nd:YAG | Nd:YAG | Identical | | Wavelength (nm) | 1064 nm | 1064 nm | Identical | | Max Fluence (J/cm²)* | 600 (J/cm²) | 600 (J/cm²) | Identical | | Handpiece Spot Sizes | 2.5 mm | 2.5 mm | Almost identical, different maximum spot size but same fluence range. | | (Diameter millimetre) | 5 mm | 5 mm | | | | 7 mm | 7 mm | | | | 10 mm | 10 mm | Change do not affect safety and effectiveness of the device | | | 12 mm | 12 mm | | | | 14 mm | 14 mm | | | | 15 mm | 15 mm | | | | 16 mm | 16 mm | | | | 18 mm | 18 mm | | | | 20 mm | 20 mm | | | | 22 mm | 22 mm | | | Device Trade Name | Subject Device AGAIN PRO family | Predicate Device K150516 SYNCHRO REPLA:Y | Comment | | | 24 mm | 24 mm | | | | 30 mm | | | | Pulse Duration (milliseconds) | 0.2 to 300 ms | 0.25 to 300 ms | Almost identical, minimum pulse duration is slightly different. Change do not affect safety and effectiveness of the device. | | Pulse Repetition Rate (Hz) | Up to 12 Hz | Up to 10 Hz | Similar, maximum frequency is slightly different. Change do not affect safety and effectiveness of the device. | | Skin Cooling System | Yes, optional | Yes, optional | Identical | {11}------------------------------------------------ {12}------------------------------------------------ *Maximum fluence is not available for all spot sizes. {13}------------------------------------------------ ## Performance Data: ## Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted on the DEKA AGAIN PRO device, according to the following standards: - . AAMI/ANSI ES60601-1- Medical 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. - . 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. ## 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 Submission for Device Software Functions". ## Conclusion: Based on the comparison of indications for use and the technological characteristics, we can conclude that DEKA AGAIN PRO device is as safe, as effective, and performs as well as the legally marketed predicate device (K150516). ### Additional Information: None.