(86 days)
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).
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.
The provided document is a 510(k) summary for the ORION Medical Laser System. This type of submission relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than conducting new clinical studies to prove effectiveness. Therefore, the document does not contain information about the acceptance criteria or a dedicated study designed to prove the device meets specific acceptance criteria in the manner of a traditional clinical trial for a novel device.
Instead, the "proof" the device meets the acceptance criteria (which are essentially equivalence to predicate devices) primarily comes from engineering and performance testing against recognized standards, and a comparison of technical specifications and intended uses with predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for substantial equivalence, "acceptance criteria" are not explicitly stated in terms of clinical performance metrics that the device must achieve. Instead, the "acceptance criteria" are implicitly that the device's technical specifications and intended uses fall within the established parameters of the predicate devices and that the device meets relevant safety and electrical standards. The "reported device performance" is a demonstration of compliance with these standards and a comparison of specifications.
| Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ORION) |
|---|---|---|
| General Safety and Performance | Compliance with relevant medical electrical equipment standards (e.g., IEC 60601 series, IEC 62366, IEC 60825-1). | Tested against: - IEC 60601-1 (general requirements for basic safety and essential performance)- IEC 60601-1-6 (usability)- IEC 62366-1 (application of usability engineering)- IEC 60601-2-22 (particular requirements for surgical/cosmetic/therapeutic/diagnostic laser equipment)- IEC 60601-1-2 (electromagnetic compatibility)- IEC 60825-1 (safety of laser products - equipment classification/requirements)Conclusion: "All the test results support substantial equivalence to the predicate devices." (Page 6) |
| Indications for Use (532nm) | Coagulation and hemostasis of vascular and cutaneous lesions in dermatology (e.g., angiomas, telangiectasia, benign pigmented lesions like nevi, lentigines, tattoos/red & green ink, verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment for hemostasis, color lightening, blanching, flattening, reduction of lesion size), similar to Altus Medical Modified CoolGlide Aesthetic Lasers (K014040). | Matched Indication: 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; cutaneous lesion treatment (hemostasis, color lightening, flattening, reduction of lesion size). (Page 5 & 6-7 Comparison Table) |
| Indications for Use (755nm) | Stable long-term/permanent hair reduction for all skin types (Fitzpatrick I-VI) including tanned skin, measured at 6, 9, 12 months post-treatment. Treatment of vascular lesions, benign pigmented lesions, and wrinkles, similar to Cynosure Apogee Elite Laser (K034030) and CLARITY LPC Laser System (K130199). | Matched Indication: Stable long-term, or permanent hair reduction (defined as long-term, stable reduction in number of hairs regrowing measured at 6, 9, and 12 months after treatment regime) for all skin types (Fitzpatrick I-VI) including tanned skin. Also indicated for treatment of vascular lesions, benign pigmented lesions, and wrinkles. (Page 5 & 7-8 Comparison Table) |
| Indications for Use (1064nm) | Coagulation and hemostasis of benign vascular lesions (e.g., port wine stains, hemangiomas, superficial venous malformations, warts, telangiectasia, rosacea, leg veins, spider veins, poikiloderma of Civatte); treatment of benign cutaneous lesions (e.g., warts, scars, striae, psoriasis); treatment of benign pigmented lesions (e.g., lentigos, solar lentigos, café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos/significant reduction in black and/or blue/black ink, plaques); treatment of wrinkles (e.g., periocular, perioral); removal of unwanted hair/stable long-term/permanent hair reduction (melanin targeting in hair follicles); treatment of pseudofolliculitis barbae (PFB). Similar to Altus Medical (K014040), Cynosure (K034030), and CLARITY (K130199). | Matched Indication: Coagulation and hemostasis of benign vascular lesions (such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins, spider veins and poikiloderma of civatte); and treatment of benign cutaneous lesions (such as warts, scars, striae and psoriasis); treatment of benign pigmented lesions (such as lentigos, solar lentigos, cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in intensity of black and/or blue/black tattoos) and plaques); treatment of wrinkles (such as periocular and perioral wrinkles). Additionally, for removal of unwanted hair, for stable long term, or permanent hair reduction (melanin targeting in hair follicles), and for treatment of pseudofolliculitis barbae (PFB). (Page 5 & 8-9 Comparison Table) |
| Technical Specifications | Technical specifications for wavelength, energy, pulse duration, and spot size should be equivalent or similar to predicate devices. | The comparison table (pages 6-9) details specifications for ORION (Subject Device) and three predicate devices across parameters like: - Technology: Long Pulse Nd:YAG (matches all predicates)- Energy (1064nm): 100J (matches all predicates)- Energy (755nm): 50J (matches Cynosure, similar to CLARITY's 55J)- Energy (532nm): 10J (matches Altus)- Frequency: Ranges are similar/within predicate's capabilities.- Pulse train duration: Ranges are similar.- Spot size: 2-20mm (within range of predicate devices).- Wavelength: 1064nm, 755nm, 532nm (combination of wavelengths available in predicate devices).- Aiming beam: 650nm (matches all predicates).- Energy source: Nd:YAG, Alexandrite, KTP (matches combinations in predicates).- Cooling method: Cold air (matches Cynosure and CLARITY, different from Altus's Sapphire cooling but the overall effectiveness for skin protection is implied to be equivalent through the general performance testing). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on non-clinical performance data and a comparison to predicate devices. There is no information provided on clinical studies involving a "test set" of patient data, nor any details on sample size, data provenance (country, retrospective/prospective). This is typical for a 510(k) where substantial equivalence is demonstrated through engineering and a comparison to previously cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical studies with a "test set" are described, there is no information on experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical studies with a "test set" are described, there is no information on an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The device is a medical laser system, not an AI-powered diagnostic or assistive tool for human "readers." Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not applicable and was not conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a medical laser system used for treatment, not an algorithm. Therefore, a standalone performance study in the context of an algorithm is not applicable and was not conducted or mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is based on:
- Established standards: Compliance with international and national safety and performance standards for medical electrical equipment and laser products (e.g., IEC 60601 series, IEC 60825-1).
- Predicate device specifications and clearances: The regulatory "ground truth" is that the predicate devices are legally marketed and have established safety and effectiveness. The ORION's specifications and intended uses are compared to these.
There is no mention of clinical "outcomes data," "pathology," or "expert consensus" related to new clinical trials for the ORION device itself.
8. The sample size for the training set
Since this is not an AI/machine learning device requiring a training set, this information is not applicable and not provided.
9. How the ground truth for the training set was established
As there is no training set for an AI/machine learning device, this information is not applicable and not provided.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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)
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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).
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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 PredicateDevice | ReferencePredicate Device | ReferencePredicate Device | |||
|---|---|---|---|---|---|---|
| Device name | ORION | Family of AltusMedical ModifiedCoolGlideAestheticLasers (PrimaryPredicate) | Cynosure ApogeeElite Laser(ReferencePredicate) | CLARITY LPCLaser System(ReferencePredicate) | ||
| Manufacturer | YERIMENGINEERINGCo., Ltd. | Altus Medical, Inc. | CYNOSURE, INC. | LutronicCorporation | ||
| 510(k) number | K161503 | K014040 | K034030 | K130199 | ||
| Technology | Long PulseNd:YAG | Long PulseNd:YAG | Long PulseNd:YAG | Long PulseNd:YAG | ||
| Power (CW Laser) | AC220 - 240V/16A | 110 - 120VAC/20A220 - 240VAC/20A | 200/220 VAC/30A | 4.0kVA(AC220~230V) | ||
| 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 ofpulse | 1064 nm | 1Hz | 2Hz | 5Hz | Up to 10Hz | |
| 755nm | 3Hz | - | 3Hz | Up to 10Hz | ||
| 532nm | 2Hz | 2Hz | n/a | |||
| Pulse trainduration | 1064 nm | 0.1~300ms | 0.3 - 300 ms | Adjustable0.4- 300 msec | 0.35 ms - 300 ms | |
| 755nm | 0.1~300ms | Adjustable0.5 – 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 isindicated forcoagulation andhemostasis ofvascular andcutaneous lesionsindermatologyincluding, but not limitedto, the followinggeneral categories:vascularlesions[angiomas,hemangiomas (portwine),telangiectasia(facial orextremitiestelangiectasias,venous anomalies, legveins)]; benignpigmented lesions(nevi, lentigines,chloasma,cafk-au-lait, tattoos (redand green ink);verrucae; skin tags;keratoses; plaques;cutaneouslesiontreatment | For coagulationand hemostasis ofvascular andcutaneous lesionsindermatologyincluding, but not limitedto, the followinggeneral categories:vascularlesions[angiomas,hemangiomas (portwine),telangiectasia(facial orextremitiestelangiectasias,venous anomalies, legveins)]; benignpigmented lesions(nevi, lentigines,chloasma,cafk-au-lait, tattoos (redand green ink);verrucae; skin tags;keratoses; plaques;cutaneouslesiontreatment(hemostasis, colorlightening, | |||
| lightening,blanching,flattening,reduction of lesionsize). | flattening,reduction of lesionsize). | The CLARITYLPC Laser Systemis indicated fortemporary hairreduction. Stablelong-term orpermanentreduction throughselective targetingof melanin in hairfollicles.Permanent hairreduction isdefined as the long-term, stablereduction in thenumber of hairsregrowing whenmeasured at 6, 9,and 12 monthsafter thecompletion of atreatment regime.On all skin types(Fitzpatrick 1-VI)including tannedskin. Treatment ofbenign pigmentedlesions. Treatmentof wrinkles. Thephotocoagulationof dermatologicalvascular lesions(such as port-winestains,hemangiomas,telangiectasias). | ||||
| 755 nm | The ORION isindicated for stablelong-term, orpermanent hairreduction.Permanent hairreduction isdefined as long-term stablereduction in thenumber of hairregrowth after atreatment regime. Itis used for all skintypes (FitzpatrickI- VI) includingtanned skin.It is also indicatedfor the treatment ofvascular lesions,benign pigmentedlesions, andwrinkles. | - | The CynosureApogee EliteDermatologicalLaser is indicatedfor stable long-term, or permanenthair reduction.Permanent hairreduction isdefined as long-term stablereduction in thenumber of hairregrowth after atreatment regime. Itis used for all skintypes (FitzpatrickI- VI) includingtanned skin.It is also indicatedfor the treatment ofvascular lesions,benign pigmentedlesions, andwrinkles. | |||
| 1064 nm | The ORION isintended for thecoagulation andhemostasis ofbenign vascularlesions such as, butnot limited to, portwine stains,hemangiomas,warts,telangiectasia, | Dermatology:The Altus MedicalAestheticCoolGlide lasersystems areintended forthecoagulation andhemostasis ofbenign vascularlesions such as, butnot limited toportwine stains, | The CynosureApogee EliteDermatologicallaser is intended forthe coagulation andhemostasis ofbenign vascularlesions such as, butnot limited to, portwine stains,hemangiomas,warts, | The CLARITYLPC Laser Systemis indicated for theremoval ofunwanted hair, forstable long term orpermanent hairreduction and fortreatment of PFB.Permanent hairreduction isdefined as the long- |
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| gastroenterology,general surgery,headandneck/otorhinolaryngology (ENT),neurosurgery,oculoplastics,orthopedics,plastic surgery,pulmonary/thoracicsurgery,gynecology (e.g.menorrhagia)andurology. | ||||||
|---|---|---|---|---|---|---|
| lake, leg veins,spider veinsandpoikiloderma ofcivatte; andtreatment of benigncutaneous lesionssuch as warts,scars, striaeandpsoriasis. The laseris also intended forthe treatment ofbenign pigmentedlesions such as, butnot limited to,lentigos (agespots), solarlentigos (sunspots), cafe au laitmacules, seborrheickeratoses, nevi,chloasma,verrucae, skin tags,keratoses, tattoos(significantreduction in the intensity ofblack and/orblue/black tattoos)and plaques.The laser is alsoindicated for thetreatment ofwrinkles such as,but not limited to,periocularandperioral wrinkles.Additionally, thelaser is indicatedfor the removal ofunwanted hair, forthe stable longterm, or permanent,hair reductionthrough selectivetargeting ofmelanin in hairfollicles, and forthetreatment ofpseudofolliculitisbarbae (PFB). | hemangiomas,warts,telangiectasia,rosacea, Venuslake, legveins andspider veins. Thelasers are alsointended for thetreatment ofbenignpigmentedlesions such as, butnot limited to,lentigos (agespots), solarlentigos(sun spots),cafe au laitmacules,seborrheickeratoses, nevi,chloasma,verrucae,skin tags,keratoses,tattoos(significantreduction in theintensity of blackand/orblue/blacktattoos) andplaques.Additionally, thelasers are indicatedforpigmentedlesions to reducelesion size, forpatients withlesions thatwouldpotentiallybenefit fromaggressivetreatment, and forpatients withlesions thathavenot responded toother lasertreatments.The CoolGlidelasers are alsoindicated for theremoval ofunwanted hair, forthestable long term,or permanent, hairreduction throughselective targeting | telangiectasia,rosacea, venuslake, leg veins,spider veinsandpoikiloderma ofcivatte; andtreatment of benigncutaneous lesionssuch as warts,scars, striaeandpsoriasis. The laseris also intended forthe treatment ofbenign pigmentedlesions such as,butnot limited to,lentigos (agespots), solarlentigos (sunspots), cafe au laitmacules, seborrheickeratoses, nevi,chloasma,verrucae, skin tags,keratoses, tattoos(significantreduction in the intensity ofblack and/orblue/black tattoos)and plaques.The laser is alsoindicated for thetreatment ofwrinkles such as,but not limited to,periocularandperioral wrinkles.Additionally, thelaser is indicatedfor the removal ofunwanted hair, forthe stable longterm,or permanent,hair reductionthrough selectivetargeting ofmelanin in hairfollicles, and forthetreatment ofpseudofolliculitisbarbae (PFB). | term, stablereduction in thenumber of hairsregrowing whenmeasured at 6, 9,and 12 monthsafter thecompletion of atreatment regime.The lasers areindicated on allskin typesFitzpatrick I-VIincluding tannedskin.Photocoagulationand hemostasis ofpigmented andvascular lesionssuch as but notlimited to port winestains,hemangiomna,warts,telangiectasia,rosacea, venuslake, leg veins andspider veins.Coagulation andhemostasis of softtissue. Benignpigmented lesionssuch as, but notlimited to. lentigos(age spots), solarlentigos (sunspots), cafe au laitmacules,seborrheickeratoses, nevi,chloasma,verrucae, skin tags,keratoses, tattoos(significant.reduction in theintensity of blackand/or blue-blacktattoos) andplaques. The laseris indicated forpigmented lesionsto reduce lesionsize, for patientswith lesions thatselective tar | |||
| ofmelanin in hairfollicles, and forthe treatment forpseudofolliculitisbarbae (PFB).The lasers are alsoindicated for thereduction of redpigmentation inhypertrophicand keloid scarswhere vascularityis an integral partof the scar.The CoolGlidelasers are indicatedfor use on all skintypes (FitzpatrickI-VI),includingtanned skin.The intended use ofthe integral coolingsystem in the Altushandpiece istoprovide coolingof the skin prior tolaser treatment, forthe reduction ofpainduring lasertreatment, to allowfor the use ofhigher fluences forlasertreatmentssuch ashair removal andvascular lesions,and to reduce thepotential sideeffectsof lasertreatments.SurgicalApplications:The lasers areindicated for theincision/excisionand cutting,ablation,coagulation/hemostatis of softtissue in theperformance ofsurgicalapplicationsinendosopy/laprosc | would potentiallybenefit fromaggressivetreatment, and forpatients withlesions that havenot responded toother lasertreatments. Thelaser is alsoindicated for thereduction of redpigmentation inhypertrophic andkeloid scars wherevascularity is anintegral part of thescar. Treatment ofwrinkles. |
{10}------------------------------------------------
{11}------------------------------------------------
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 Yerim engineering Co., Ltd. believes that the ORION is substantially equivalent to the predicate device, Family of Altus Medical Modified CoolGlide Aesthetic Lasers (K014040, Altus Medical, Inc.), Cynosure Apogee Elite Laser (K034030, Cynosure, Inc.) and CLARITY LPC Laser System (K130199, Lutronic Corporation). ORION has the same intended use, performance specifications, and similar operational characteristics as the predicate devices. Performance data supports that the device is substantially as safe and effective as the predicate devices for its intended use. Therefore, ORION may be found substantially equivalent to its predicate devices.
Conclusion: 9.
Based on the testing results, YERIM ENGINEERING Co., Ltd. concludes that the ORION is substantially equivalent to the predicate device.
§ 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.