(48 days)
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).
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.
This document describes a 510(k) premarket notification for the ELEMENT-TL medical laser system. The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than to prove safety and effectiveness through clinical trials in the same way a PMA (Pre-Market Approval) would.
Therefore, the study supporting this submission is not a clinical study demonstrating improved human reader performance with AI, or a standalone algorithm performance study. Instead, it is focused on non-clinical performance data and a direct comparison to a predicate device to establish substantial equivalence.
Here's an analysis based on the provided text, addressing your questions where applicable, and noting where information is not present given the nature of a 510(k) submission for this type of device:
Device: ELEMENT-TL
Predicate Device: ORION by YERIM ENGINEERING Co., Ltd. (K161503)
Type of Study: This is a premarket notification (510(k)) which relies on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, rather than a clinical trial or AI performance study with human readers.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly met by demonstrating compliance with recognized electrical safety, electromagnetic compatibility, usability, and laser safety standards, and by showing that the technical specifications are comparable to the predicate device. The performance data presented are primarily non-clinical, showing adherence to these standards.
| Acceptance Criteria (Implied by Standards & Predicate Comparison) | Reported Device Performance (Non-Clinical) |
|---|---|
| Electrical Safety (IEC 60601-1) | Complies with standard |
| Usability (IEC 60601-1-6, IEC 62366-1) | Complies with standard |
| Laser Safety & Performance (IEC 60601-2-22, IEC 60825-1) | Complies with standards (Radiology) |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with standard (General II (ES/EMC)) |
| Technical Specifications (e.g., Wavelength, Energy, Frequency, Spot Size) | Matches or is within acceptable range of predicate device (see comparison table below) |
| Indications for Use | Identical to predicate device |
Key Performance Data (Technical Comparison to Predicate):
| Feature | Subject Device (ELEMENT-TL) | Predicate Device (ORION) |
|---|---|---|
| Technology | Long Pulse Nd:YAG | Long Pulse Nd:YAG |
| Power (CW Laser) | AC220 - 240 V/16A | AC220 - 240 V/16A |
| Energy (1064nm) | 100J | 100J |
| Energy (755nm) | 50J | 50J |
| Energy (532nm) | 10J | 10J |
| Pulsed Operation | Long pulse | Long pulse |
| Frequency (1064nm) | 1Hz | 1Hz |
| Frequency (755nm) | 3Hz | 3Hz |
| Frequency (532nm) | 2Hz | 2Hz |
| Pulse Train Duration (all wavelengths) | 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 | Identical to predicate device across all wavelengths (532nm, 755nm, 1064nm) | Identical to subject device |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of clinical patient data here. The "test set" refers to the device itself being tested for compliance with standards and comparison to a predicate, not a dataset of patient images or outcomes.
- Data Provenance: Not applicable for patient data. The non-clinical testing was performed on the device itself. The origin of the predicate device (YERIM ENGINEERING Co., Ltd.) is Republic of Korea.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This information is not provided and is generally not required for a 510(k) submission of a laser surgical instrument, which doesn't involve subjective interpretation of medical images by human experts. The "ground truth" here is compliance with engineering and safety standards, and functional equivalence to the predicate device's specifications.
4. Adjudication Method for the Test Set
- Not applicable. There is no adjudication of subjective interpretations as this is not a study involving human readers and interpretations of medical data. Performance is assessed against objective engineering standards and technical specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was not done. This device is a laser surgical instrument, not an AI-based diagnostic or assistive software. Therefore, there is no AI assistance for human readers, and no "effect size of how much human readers improve" to report.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device, not a standalone algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is based on compliance with recognized international and national consensus standards (IEC standards for medical electrical equipment, laser safety, and usability) and direct comparison of the device's technical specifications and indications for use to a legally marketed predicate device. There is no reliance on expert consensus (e.g., radiology reads), pathology, or patient outcomes data in this 510(k) summary for establishing substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
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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
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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
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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.
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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 andplastic 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)
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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.
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).
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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 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 ENGINEERINGCo., 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 andsuper pulse) | 1064nm | 100J | 100J |
| 755nm | 50J | 50J | |
| 532nm | 10J | 10J | |
| If pulsed, how is this done | Long pulse | Long pulse | |
| Frequency ofpulse | 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 | 532nmThe ELEMENT-TL is indicatedfor coagulation and hemostasisof vascular and cutaneouslesions in dermatologyincluding, but not limited to, thefollowing general categories:vascular lesions[angiomas,hemangiomas (port wine),telangiectasia (facial orextremitiestelangiectasias, venousanomalies, leg veins)]; benignpigmented lesions (nevi,lentigines, chloasma, cafk-au-lait, tattoos (red and green ink);verrucae; skin tags; keratoses;plaques; cutaneouslesiontreatment (hemostasis, colorlightening, blanching, flattening,reduction of lesion size).755 nmThe ELEMENT-TL is indicatedfor stable long-term, orpermanent hair reduction whichis defined as the long-term,stable reduction in the numberof hairs regrowing whenmeasured at 6, 9, and 12 monthsafter the completion of atreatment regime. It is used forall skin types (Fitzpatrick I- VI)including tanned skin It is also | 532nmThe ORION is indicated forcoagulation and hemostasis ofvascular and cutaneous lesionsin dermatology including, butnot limited to, the followinggeneral categories: vascularlesions[angiomas,hemangiomas (port wine),telangiectasia (facial orextremitiestelangiectasias,venousanomalies, leg veins)]; benignpigmented lesions (nevi,lentigines, chloasma, cafk-au-lait, tattoos (red and greenink); verrucae; skin tags;keratoses; plaques;cutaneouslesion treatment(hemostasis, color lightening,blanching, flattening,reduction of lesion size).755 nmThe ORION is indicated forstable long-term, or permanenthair reduction which isdefined as the long-term,stable reduction in the numberof hairs regrowing whenmeasured at 6, 9, and 12months after the completion ofa treatment regime. It is usedfor all skin types (FitzpatrickI- VI) including tanned skin. It |
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| vascular lesions, benignpigmented lesions, and wrinkles. | is also indicated for thetreatment of vascular lesions,benign pigmented lesions, andwrinkles. |
|---|---|
| 1064nmThe ELEMENT-TL is intendedfor the coagulation andhemostasis of benign vascularlesions such as, but not limitedto, port wine stains,hemangiomas, warts,telangiectasia, rosacea, venuslake, leg veins, spider veins andpoikiloderma of civatte; andtreatment of benign cutaneouslesions such as warts, scars,striae and psoriasis. The laser isalso intended for the treatmentof benign pigmented lesionssuch as, but not limited to,lentigos (age spots), solarlentigos (sun spots), cafe au laitmacules, seborrheic keratoses,nevi, chloasma, verrucae, skintags, keratoses, tattoos(significant reduction in theintensity of black and/orblue/black tattoos) and plaques.The laser is also indicated forthe treatment of wrinkles suchas, but not limited to, periocularand perioral wrinkles.Additionally, the laser isindicated for the removal ofunwanted hair, for the stablelong term, or permanent hairreduction which is defined as thelong-term, stable reduction inthe number of hairs regrowingwhen measured at 6, 9, and 12months after the completion of atreatment regime throughselective targeting of melanin inhair follicles, and for thetreatment of pseudofolliculitisbarbae (PFB). | 1064nmThe ORION is intended forthe coagulation andhemostasis of benign vascularlesions such as, but not limitedto, port wine stains,hemangiomas, warts,telangiectasia, rosacea, venuslake, leg veins, spider veinsand poikiloderma of civatte;and treatment of benigncutaneous lesions such aswarts, scars, striae andpsoriasis. The laser is alsointended for the treatment ofbenign pigmented lesions suchas,but not limited to, lentigos(age spots), solar lentigos (sunspots), cafe au lait macules,seborrheic keratoses, nevi,chloasma, verrucae, skin tags,keratoses, tattoos (significantreduction in the intensity ofblack and/or blue/blacktattoos) and plaques.The laser is also indicated forthe treatment of wrinkles suchas, but not limited to,periocular and perioralwrinkles. Additionally, thelaser is indicated for theremoval of unwanted hair, forthe stable long term, orpermanent hair reductionwhich is defined as the long-term, stable reduction in thenumber of hairs regrowingwhen measured at 6, 9, and 12months after the completion ofa treatment regime throughselective targeting of melaninin hair follicles, and for thetreatment of pseudofolliculitisbarbae (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.
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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.
§ 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.