← Product Code [GEX](/productcode/GEX) · K180224 # ELEMENT-TL (K180224) _Elemenic Co., Ltd. · GEX · Mar 15, 2018 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K180224 ## Device Facts - **Applicant:** Elemenic Co., Ltd. - **Product Code:** [GEX](/productcode/GEX.md) - **Decision Date:** Mar 15, 2018 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use 532nm The ELEMENT-TL is indicated for coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lessons angiomas (port wine), telangiectasia (facial or extremities telangiectasias.venous anomalies, leg veins); benien pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneouslesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size). 755 nm The ELEMENT-TL is indicated for stable long-term, or permanent hair reduction which 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. It is used for all skin types (Fitzpatrick I- VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 1064nm The ELEMENT-TL is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), safe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent hair reduction which 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 targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB). ## Device Story ELEMENT-TL is a medical laser system for dermatology; utilizes 532nm, 755nm, and 1064nm wavelengths. System comprises main body and handpiece; controlled by microprocessor interfaced with LCD touch screen. Physician operates device; activates laser via handpiece switch. Laser energy targets melanin in hair follicles or vascular/pigmented lesions to achieve coagulation, hemostasis, or hair reduction. Device provides clinical benefit through lesion treatment and permanent hair reduction. Differences from predicate include housing, button locations, and UI; these do not impact safety or performance. ## Clinical Evidence Bench testing only. Compliance with IEC 60601-1 (safety/performance), IEC 60601-1-6 (usability), IEC 62366-1 (usability engineering), IEC 60601-2-22 (laser safety), IEC 60601-1-2 (EMC), and IEC 60825-1 (laser product safety). ## Technological Characteristics Long Pulse Nd:YAG laser system; wavelengths 532nm, 755nm, 1064nm. Energy source: Nd:YAG, Alexandrite, KTP. Cooling: Cold air. Microprocessor-controlled with LCD touch screen interface. Standards: IEC 60601-1, IEC 60601-1-6, IEC 62366-1, IEC 60601-2-22, IEC 60601-1-2, IEC 60825-1. ## Regulatory 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 - ORION by YERIM ENGINEERING Co., Ltd. ([K161503](/device/K161503.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration." March 15, 2018 ELEMENIC Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt Irvine, California 92620 Re: K180224 Trade/Device Name: ELEMENT-TL 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: January 19, 2018 Received: January 26, 2018 Dear Priscilla Chung: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misl eading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good {1}------------------------------------------------ manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). > Sincerely, Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K180224 Device Name ELEMENT-TL ## Indications for Use (Describe) ## 532mm The ELEMENT-TL is indicated for coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lessons angiomas (port wine), telangiectasia (facial or extremities telangiectasias.venous anomalies, leg veins); benien pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneouslesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size). 755 nm The ELEMENT-TL is indicated for stable long-term, or permanent hair reduction which 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. It is used for all skin types (Fitzpatrick I- VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. ## 1064nm The ELEMENT-TL is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), safe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent hair reduction which 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 targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB). | 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. {3}------------------------------------------------ # 510(k) Summary This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: ____March 13, 2018____ #### 1. Applicant / Submitter: ELEMENIC Co., Ltd. 3rd, 34 , Gyeongin-ro 3beon-gil, Bucheon-si, Gyeonggi-do, 14731 Republic of Korea Tel : +82-32-613-5007 Fax : +82-32-613-5009 #### 2. Submission Correspondent: Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine CA 92620 Fax: 714-409-3357 Phone: 714-202-5789 Email: juhee.c@lkconsultinggroup.com #### 3. Device: | Proprietary Name: | ELEMENT-TL | |------------------------------|----------------------------------------------------------------------------------------| | Common Name: | Medical Laser System | | Classification Name: | Laser surgical instrument for use in general and
plastic surgery and in dermatology | | Classification: | Class II, 21 CFR 878.4810 | | Classification Product Code: | GEX | #### 4. Predicate Device: ORION by YERIM ENGINEERING Co., Ltd. (K161503) {4}------------------------------------------------ #### 5. Device Description: The subject device is composed of the main body and a handpiece which is an irradiation device and as an accessory part, protective goggles for protection of the worker. This equipment is controlled by a micro-processor interfaced to a LCD touch screen control panel. The computer controls start and stop of the treatment. When the key switch of the system is turned clockwise, the main power will be inputted, which will be conveyed to the hand piece through the control board. Meanwhile, the control board connected to the touch screen is connected to the lamp of the handpiece and controls the same, and controls the whole system through the data connected to the touch screen control panel. When the switch of the hand piece is pressed, the lamp will laser. #### 6. Indications for Use: ## 532nm The ELEMENT-TL is indicated for coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions[angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink): verrucae: skin tags: keratoses: plaques: cutaneouslesion treatment (hemostasis, color lightening, flattening, reduction of lesion size). ## 755 nm The ELEMENT-TL is indicated for stable long-term, or permanent hair reduction which 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. It is used for all skin types (Fitzpatrick I- VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. ## 1064nm The ELEMENT-TL is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte: and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as,but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent hair reduction which 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 through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB). {5}------------------------------------------------ #### Performance Data(Non-Clinical): 7. The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices. - . IEC 60601-1 Medical electrical equipment - part 1: general requirements for basic safety and essential performance - IEC 60601-1-6 Medical electrical equipment part 1-6: general requirements for basic safety . and essential performance - collateral standard: usability. - IEC 62366-1 Medical devices part 1: application of usability engineering to medical devices. . - . 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. (Radiology) - . IEC 60601-1-2 Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests. (General II (ES/EMC)) - . IEC 60825-1 Edition 2.0 2007-03, safety of laser products - part 1: equipment classification. and requirements [including: technical corrigendum 1 (2008), interpretation sheet 1 (2007), interpretation sheet 2 (2007)]. (Radiology) #### 8. Substantial Equivalence The ELEMENIC-TL is substantially equivalent to the ORION by YERIM ENGINEERING Co., Ltd. (K161503). The following comparison table is presented to demonstrate substantial equivalence. | | Subject Device | Primary Predicate Device | | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | Device name | ELEMENT-TL | ORION | | | Manufacturer | ELEMENIC Co., Ltd. | YERIM ENGINEERING
Co., Ltd. | | | 510(k) number | K180224 | K161503 | | | Technology | Long Pulse Nd:YAG | Long Pulse Nd:YAG | | | Power (CW Laser) | AC220 - 240 V/16A | AC220 - 240 V/16A | | | Energy
(pulse and
super pulse) | 1064nm | 100J | 100J | | | 755nm | 50J | 50J | | | 532nm | 10J | 10J | | If pulsed, how is this done | Long pulse | Long pulse | | | Frequency of
pulse | 1064 nm | 1Hz | 1Hz | | | 755nm | 3Hz | 3Hz | | | 532nm | 2Hz | 2Hz | | | 1064 nm | 0.1~300ms | 0.1~300ms | | Pulse train duration | 755nm | 0.1~300ms | 0.1~300ms | | | 532nm | 0.1~300ms | 0.1~300ms | | Spot size at target | | 2~20mm | 2~20mm | | Wavelength | | 1064 nm,
755nm,
532nm | 1064 nm,
755nm,
532nm | | Aiming beam | | 650nm | 650 nm | | Energy source | | Nd:YAG,
Alexandrite,
KTP | Nd:YAG,
Alexandrite,
KTP | | Cooling method | | Cold air | Cold air | | Indications for Use | 532nm
The ELEMENT-TL is indicated
for coagulation and hemostasis
of vascular and cutaneous
lesions in dermatology
including, but not limited to, the
following general categories:
vascular lesions[angiomas,
hemangiomas (port wine),
telangiectasia (facial or
extremities
telangiectasias, venous
anomalies, leg veins)]; benign
pigmented lesions (nevi,
lentigines, chloasma, cafk-au-
lait, tattoos (red and green ink);
verrucae; skin tags; keratoses;
plaques; cutaneouslesion
treatment (hemostasis, color
lightening, blanching, flattening,
reduction of lesion size).
755 nm
The ELEMENT-TL is indicated
for stable long-term, or
permanent hair reduction which
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. It is used for
all skin types (Fitzpatrick I- VI)
including tanned skin It is also | 532nm
The ORION is indicated for
coagulation and hemostasis of
vascular and cutaneous lesions
in dermatology including, but
not limited to, the following
general categories: vascular
lesions[angiomas,
hemangiomas (port wine),
telangiectasia (facial or
extremities
telangiectasias,venous
anomalies, leg veins)]; benign
pigmented lesions (nevi,
lentigines, chloasma, cafk-au-
lait, tattoos (red and green
ink); verrucae; skin tags;
keratoses; plaques;
cutaneouslesion treatment
(hemostasis, color lightening,
blanching, flattening,
reduction of lesion size).
755 nm
The ORION is indicated for
stable long-term, or permanent
hair reduction which 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. It is used
for all skin types (Fitzpatrick
I- VI) including tanned skin. It | | {6}------------------------------------------------ {7}------------------------------------------------ | vascular lesions, benign
pigmented lesions, and wrinkles. | is also indicated for the
treatment of vascular lesions,
benign pigmented lesions, and
wrinkles. | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1064nm
The ELEMENT-TL is intended
for the coagulation and
hemostasis of benign vascular
lesions such as, but not limited
to, port wine stains,
hemangiomas, warts,
telangiectasia, rosacea, venus
lake, leg veins, spider veins and
poikiloderma of civatte; and
treatment of benign cutaneous
lesions such as warts, scars,
striae and psoriasis. The laser is
also intended for the treatment
of benign pigmented lesions
such as, but not limited to,
lentigos (age spots), solar
lentigos (sun spots), cafe au lait
macules, seborrheic keratoses,
nevi, chloasma, verrucae, skin
tags, keratoses, tattoos
(significant reduction in the
intensity of black and/or
blue/black tattoos) and plaques.
The laser is also indicated for
the treatment of wrinkles such
as, but not limited to, periocular
and perioral wrinkles.
Additionally, the laser is
indicated for the removal of
unwanted hair, for the stable
long term, or permanent hair
reduction which 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 through
selective targeting of melanin in
hair follicles, and for the
treatment of pseudofolliculitis
barbae (PFB). | 1064nm
The ORION is intended for
the coagulation and
hemostasis of benign vascular
lesions such as, but not limited
to, port wine stains,
hemangiomas, warts,
telangiectasia, rosacea, venus
lake, leg veins, spider veins
and poikiloderma of civatte;
and treatment of benign
cutaneous lesions such as
warts, scars, striae and
psoriasis. The laser is also
intended for the treatment of
benign pigmented lesions such
as,but not limited to, lentigos
(age spots), solar lentigos (sun
spots), cafe au lait macules,
seborrheic keratoses, nevi,
chloasma, verrucae, skin tags,
keratoses, tattoos (significant
reduction in the intensity of
black and/or blue/black
tattoos) and plaques.
The laser is also indicated for
the treatment of wrinkles such
as, but not limited to,
periocular and perioral
wrinkles. Additionally, the
laser is indicated for the
removal of unwanted hair, for
the stable long term, or
permanent hair reduction
which 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 through
selective targeting of melanin
in hair follicles, and for the
treatment of pseudofolliculitis
barbae (PFB). | In reference to the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and the information provided on the device comparison table and performance test results, the ELEMENIC Co., Ltd. {8}------------------------------------------------ believes that the ELEMENIC-TL is substantially equivalent to the predicate device, ORION (K161503, YERIM ENGINEERING Co., Ltd.). ELEMENT-TL has the same intended use, performance specifications, and similar operational characteristics as the predicate devices. The differences might be in device housing, button locations, and display UI, however, these differences do not raise an issue in safety and performance. And the performance data supports that the device is substantially as safe and effective as the predicate devices for its intended use. Therefore, ELEMENT-TL may be found substantially equivalent to its predicate devices. #### Conclusion: 9. Based on the testing results, ELEMENIC Co., Ltd. concludes that the ELEMENIC-TL is substantially equivalent to the predicate device. --- **Source:** [https://fda.innolitics.com/device/K180224](https://fda.innolitics.com/device/K180224) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com