Who is the manufacturer of ORION?

Yerim Engineering Co., Ltd. filed the 510(k) submission for ORION (K161503).

What is the FDA product code for ORION?

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 ORION?

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

Who can help prepare an FDA 510(k) submission like ORION?

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.

ORION

K161503 · Yerim Engineering Co., Ltd. · GEX · Aug 26, 2016 · General, Plastic Surgery

Device Facts

Record ID	K161503
Device Name	ORION
Applicant	Yerim Engineering Co., Ltd.
Product Code	GEX · General, Plastic Surgery
Decision Date	Aug 26, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

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 (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 is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 1064 nm 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, spider veins and poikiloderma of civate; 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).

Device Story

Orion is a medical laser system for dermatology; utilizes 532nm, 755nm, and 1064nm wavelengths. System comprises main body, handpiece, and protective goggles. Physician-operated via LCD touch screen control panel; microprocessor manages laser emission. Device targets melanin in hair follicles or vascular/pigmented lesions to achieve coagulation, hemostasis, or hair reduction. Cold air cooling used for skin protection. Output is laser energy delivered to target tissue; clinical decision-making based on visual assessment of lesions or hair growth. Benefits include lesion size reduction, color lightening, and stable long-term hair reduction.

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, Alexandrite, and KTP laser system. Wavelengths: 532nm, 755nm, 1064nm. Pulse duration: 0.1-300ms. Spot size: 2-20mm. Cooling: Cold air. Interface: Microprocessor-controlled LCD touch screen. Power: AC220-240V/16A.

Indications for Use

Indicated for patients requiring coagulation/hemostasis of vascular/cutaneous lesions, treatment of benign pigmented lesions, wrinkles, pseudofolliculitis barbae, and permanent hair reduction. Applicable to all skin types (Fitzpatrick I-VI) including tanned skin.

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

Family of Altus Medical Modified Cool Glide Aesthetic Lasers (K014040)

Reference Devices

Cynosure Apogee Elite Laser (K034030)
CLARITY LPC Laser System (K130199)

Submission Summary (Full Text)

{0}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, resembling an eagle or bird in flight. The figure is composed of three overlapping profiles, creating a sense of depth and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 26, 2016 Yerim Engineering Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine, California 92620 Re: K161503 Trade/Device Name: Orion 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: May 23, 2016 Received: June 1, 2016 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 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. 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 {1}------------------------------------------------ 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Christopher J. Ronk -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) K161503 Device Name ORION # Indications for Use (Describe) ### 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 (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 is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. # 1064 nm 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, spider veins and poikiloderma of civate; 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). | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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." {4}------------------------------------------------ # 510(k) Summary (K161503) This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: ____Aug 19, 2016____ #### 1. Applicant / Submitter: YERIM ENGINEERING Co., Ltd. Ga-307, Techno-zone ,117, Hwanggeum-ro, Yangchon-eup, Gimpo-si, Gyeonggi-do 415-843 Republic of Korea Tel : +82-31-991-9841 Fax : +82-31-991-9845 #### 2. Submission Correspondent: Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine CA 92620 Phone: 714-202-5789, Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com #### 3. Device: | Proprietary Name: | ORION | |------------------------------|--------------------------------------| | Common Name: | Medical Laser System | | Classification Name: | Instrument, Surgical, Powered, Laser | | Classification: | Class II, 21 CFR 878.4810 | | Classification Product Code: | GEX | #### 4. Predicate Device: ■ Primary Predicate Device: Family of Altus Medical Modified Cool Glide Aesthetic Lasers by Altus Medical, Inc. (K014040) ■ Reference Predicate Device: Cynosure Apogee Elite Laser by CYNOSURE, INC. (K034030) CLARITY LPC Laser System by Lutronic Corporation (K130199) {5}------------------------------------------------ #### 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. It 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 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 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 is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. ## 1064 nm 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 (sigmificant 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). {6}------------------------------------------------ #### 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 ORION is substantially equivalent to the Family of Altus Medical Modified Cool Glide Aesthetic Lasers by Altus Medical, Inc. (K014040), Cynosure Apogee Elite Laser by CYNOSURE, INC. (K034030) and CLARITY LPC Laser System by Lutronic Corporation (K130199). The following comparison table is presented to demonstrate substantial equivalence. | | | Subject Device | Primary Predicate Device | Reference Predicate Device | Reference Predicate Device | | |-----------------------------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | | | | Device name | | ORION | Family of Altus Medical Modified CoolGlide Aesthetic Lasers (Primary Predicate) | Cynosure Apogee Elite Laser (Reference Predicate) | CLARITY LPC Laser System (Reference Predicate) | | | Manufacturer | | YERIM ENGINEERING Co., Ltd. | Altus Medical, Inc. | CYNOSURE, INC. | Lutronic Corporation | | | 510(k) number | | K161503 | K014040 | K034030 | K130199 | | | Technology | | Long Pulse Nd:YAG | Long Pulse Nd:YAG | Long Pulse Nd:YAG | Long Pulse Nd:YAG | | | Power (CW Laser) | | AC220 - 240 V/16A | 110 - 120 VAC/20A 220 - 240 VAC/20A | 200/220 VAC/30A | 4.0kVA(AC220~2 30V) | | | Energy | 1064nm | 100J | 100J | 100J | 100J | | | (pulse and | 755nm | 50J | - | 50J | 55J | | | super pulse) | 532nm | 10J | 10J | n/a | n/a | | | If pulsed, how is this done | | Long pulse | Long pulse | Long pulse | Long pulse | | | Frequency of pulse | 1064 nm | 1Hz | 2Hz | 5Hz | Up to 10Hz | | | | 755nm | 3Hz | - | 3Hz | Up to 10Hz | | | | 532nm | 2Hz | 2Hz | | n/a | | | Pulse train duration | 1064 nm | 0.1~300ms | 0.3 - 300 ms | Adjustable 0.4- 300 msec | 0.35 ms - 300 ms | | | | 755nm | 0.1~300ms | | Adjustable 0.5 – 300 msec | 0.35 ms - 300 ms | | | | 532nm | 0.1~300ms | 0.3 - 300 ms | | | | | Spot size at target | | 2~20mm | 10mm | 3~24mm | 2, 3, 5, 8, 10, 12, 15, 18, 20 mm | | | Wavelength | | 1064 nm, 755nm, 532nm | 1064 nm, 532nm | 1064 nm, 755nm | 1064 nm, 755nm | | | Aiming beam | | 650nm | 650 nm | 650nm | 650nm | | | Energy source | | Nd:YAG, Alexandrite, KTP | Nd-YAG, KTP | Nd:YAG, Alexandrite | Nd:YAG, Alexandrite | | | Cooling method | | Cold air | Sapphire cooling | Cold air | Cold air | | | Intended use | 532nm | The ORION is indicated for coagulation and hemostasis of vascular and cutaneous lesions in dermatologyincludi ng, but not limited to, the following general categories: vascular lesions[angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias,ven ous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma,cafk-au- lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneouslesion treatment | For coagulation and hemostasis of vascular and cutaneous lesions in dermatologyincludi ng, but not limited to, the following general categories: vascular lesions[angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias,ven ous 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, | | | | | | | lightening, blanching, flattening, reduction of lesion size). | flattening, reduction of lesion size). | | | The CLARITY LPC Laser System is indicated for temporary hair reduction. Stable long-term or permanent 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 1-VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). | | | 755 nm | The ORION is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long- term stable reduction in the number of hair regrowth after 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. | - | The Cynosure Apogee Elite Dermatological Laser is indicated for stable long- term, or permanent hair reduction. Permanent hair reduction is defined as long- term stable reduction in the number of hair regrowth after 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. | | | | | 1064 nm | 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, | Dermatology: The Altus Medical Aesthetic CoolGlide laser systems are intended for thecoagulation and hemostasis of benign vascular lesions such as, but not limited toport wine stains, | The Cynosure Apogee Elite Dermatological laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, | | The CLARITY LPC Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. Permanent hair reduction is defined as the long- | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ |…

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