(66 days)
755nm
The Nobleen Long Pulsed Alexandrite & Nd:YAG Laser is indicated for temporary hair reduction.
Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re growing after a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. 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. Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains,
hemangiomas, telangiectasias).
1064nm
The Nobleen Long Pulsed Alexandrite & Nd: YAG Laser 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-term, stable reduction in the number of hairs re growing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types
Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea. Venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratosis. nevi, chloasma, verrucae, skin tags, keratos (signi flcant reduction in the intensity of black and/or blue-black tattoos) and plaques.
The laser is indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.
The Nobleen Long pulsed Alexandrite & Nd: Y AG Laser System contains two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 mm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Rapid Cooling System (RCS) protects the upper layers of the skin with a cooling burst of cryogen.
The provided text describes the regulatory clearance of the "Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System" by the FDA. However, it explicitly states that no clinical studies were needed or performed to support this 510(k) Premarket Notification because of the device's substantial equivalence to a legally marketed predicate device (Candela GentleMax Family of Laser Systems K133283).
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance, as these elements are typically part of clinical validation studies, which were not conducted for this specific device clearance.
The document focuses on non-clinical performance data to establish substantial equivalence, primarily through bench testing, electrical safety, electromagnetic compatibility (EMC), and software verification.
Here's what the document does provide in relation to "acceptance criteria" and "device performance" in the context of a 510(k) without clinical studies:
1. A table of pseudo-acceptance criteria (based on equivalence to predicate) and reported device performance:
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance |
|---|---|
| Safety & Performance Standards Compliance: | |
| - Electrical Safety (IEC 60601-1) | - Conformed to IEC 60601-1 (Medical electrical equipment, Part 1: General requirements for basic safety and essential performance). |
| - Electromagnetic Compatibility (IEC 60601-1-2) | - Conformed to IEC 60601-1-2 (Collateral Standard: Electromagnetic Compatibility - Requirements and Tests, 3rd ed.). |
| - Laser Safety (IEC 60825-1) | - Conformed to IEC 60825-1. |
| - Usability (IEC 62366 & IEC 60601-1-6) | - Conformed to IEC 62366 and IEC 60601-1-6. |
| - Specific Laser Requirements (IEC 60601-2-22) | - Conformed to IEC 60601-2-22. |
| Functional Equivalence to Predicate Device: | |
| - Intended Use | - Same intended uses as the predicate device. |
| - Indications for Use | - Similar indications for use as the predicate device. |
| - Technological Characteristics (e.g., wavelengths, energy, spot size, delivery system, cooling) | - Same wavelengths (755 nm and 1064 nm).- Same maximum delivered energy.- Similar spot size.- Identical 1000 µ optical fiber handpiece delivery system.- Similar operating principles.- Both use a short burst of cryogen spray (Rapid Cooling System - RCS) for skin cooling. Bench testing confirmed performance specifications were "identical to the predicate device" and that the Nobelenn system performs "according to specifications and functions as intended." |
| - Software Performance | - Software verification testing conducted; results found acceptable for software release, performed per FDA guidance ("Guidance for the Content of Premarket Submission for Software Contained in Medical Devices"). |
Remaining points (2-9) cannot be answered from the provided text as they relate to clinical studies that were explicitly stated as not performed:
- Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
- 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: Not applicable. This is a laser system, not an AI diagnostic device, and no clinical studies were performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a laser system, not an AI diagnostic device, and no clinical studies were performed.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical ground truth was established as no clinical studies were needed.
- The sample size for the training set: Not applicable. No training set for clinical data was mentioned as no clinical studies were needed.
- How the ground truth for the training set was established: Not applicable.
In summary, the FDA clearance for the "Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System" relied on demonstrating substantial equivalence to an existing predicate device through non-clinical performance testing and compliance with recognized standards, rather than new clinical efficacy or safety studies.
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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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
FineMEC Co., Ltd. Mr. William McGrail Principal McGrail Consulting, LLC 62 Dale Road Meredith, New Hampshire 03253
November 30, 2018
Re: K182663
Trade/Device Name: Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: September 24, 2018 Received: September 25, 2018
Dear William McGrail:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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,
Neil R.P.
Ogden
Digitally signed by
Neil R.P. Ogden
Date: 2018.11.30
11:41:44 -05'00'
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) K182663
Device Name
Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System
Indications for Use (Describe)
755nm
The Nobleen Long Pulsed Alexandrite & Nd: Y AG Laser is indicated for temporary hair reduction.
Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re growing after a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. 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. Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains,
hemangiomas, telangiectasias).
1064nm
The Nobleen Long Pulsed Alexandrite & Nd: YAG Laser 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-term, stable reduction in the number of hairs re growing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types
Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea. Venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratosis. nevi, chloasma, verrucae, skin tags, keratos (signi flcant reduction in the intensity of black and/or blue-black tattoos) and plaques.
The laser is indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.
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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Section 5.
510(k) Summary
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Image /page/5/Picture/0 description: The image shows the logo for FineMEC. The logo consists of a stylized symbol on the left and the word "FineMEC" on the right. The symbol is a black shape with curved lines, and the word "FineMEC" is written in a bold, sans-serif font, also in black.
510(k) Summary (As Required by 21.CFR.807.92)
-
- SUBMITTER
FineMEC Co., Ltd. Manufacturer: #604-1, 217, Heojun-ro, Gangseo-gu Seoul, Korea 07531
- SUBMITTER
Contact Person: William H. McGrail McGrail Consulting, LLC 62 Dale Road Meredith, NH 03253 Phone: (978) 808-0420 Email: bill(@mcgrailconsulting.com
Date Prepared: November 28, 2018
2. DEVICE INFORMATION
| Trade/Device Name(s): | Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System |
|---|---|
| Regulation Number: | 21 CFR § 878.4810 |
| Device Classification Name: | Powered Laser Surgical Instrument |
| Regulation Class: | Class II |
| Classification Product Code: | GEX |
| 510k Review Panel: | General & Plastic Surgery |
3. PREDICATE DEVICES
Candela Corporation, CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS (K133283) Reference Device: FineMEC Co., LTD, Noblex Long Pulse Alexandrite Lase (K143666)
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Image /page/6/Picture/0 description: The image shows the logo for FineMEC. The logo consists of a stylized symbol on the left and the word "FineMEC" on the right. The symbol is a black shape with curved lines, and the word "FineMEC" is written in a bold, sans-serif font, also in black.
4. DEVICE DESCRIPTION
The Nobleen Long pulsed Alexandrite & Nd: Y AG Laser System contains two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 mm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Rapid Cooling System (RCS) protects the upper layers of the skin with a cooling burst of cryogen.
5. INDICATIONS FOR USE
755mm
The Nobleen Long Pulsed Alexandrite & Nd:YAG Laser 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 long-term stable reduction in the number of hairs re growing after a treatment regime. On all skin types
(Fitzpatrick I- VI) including tanned skin. 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.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
1064nm
The Nobleen Long Pulsed Alexandrite & Nd:YAG 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-term, stable reduction in the number of hairs re growing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types
Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea. Venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis. nevi, chloasma, verrucae, skin tags, keratosis. tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
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The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System has the same intended use and similar indications for use, technological characteristics and operating principles as the Candela GentleMax Family of Laser System (K133283) predicate.
The Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System and the predicate deliver laser energy through an identical 1000 u optical fiber handpiece delivery system, which can output either 755 nm or 1064 nm wavelengths. The output of Nobleen Long Pulsed Alexandrite & Nd:YAG Laser system and the predicate is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch (footswitch) is used to control the delivery of laser pulses for both Nobleen Long Pulsed Alexandrite & Nd:YAG Laser System and the predicate device. The Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System and the predicate both use a short burst of cryogen spray prior to firing the laser pulse to cool the skin. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of laser light on the skin. The cryogen for both Nobleen Long Pulsed Alexandrite & Nd:YAG Laser system and the predicate, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece.
7. PERFORMANCE DATA
Testing to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22 and IEC 60825-1 has been conducted on the Nobleen Long Pulsed Alexandrite & Nd: Y AG Laser System. Bench testing has also been performed to show that the performance specifications of Nobleen Long Pulsed Alexandrite & Nd:YAG Laser System is identical to the predicate device. All performance testing demonstrated that the Nobleen Long Pulsed Alexandrite & Nd:YAG Laser System performs according to specifications and functions as intended.
The following non-clinical testing was performed on the Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System. These tests verified that the output of the Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System was identical to the predicate device.
Electrical Safety and Electromagnetic Compatibility: Electrical safety and electromagnetic compatibility (EMC) testing for the Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System was conducted by an independent test laboratory in accordance with IEC 60601-1, Medical
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electrical equipment, Part 1: General requirements for basic safety and essential performance and with IEC 60601-1-2, Collateral Standard: Electromagnetic Compatibility - Requirements and Tests, 3rd ed. The Nobleen Long Pulsed Alexandrite & Nd:YAG Laser System was determined to be in conformance with applicable IEC standards (IEC 62366, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1).
Software: Software verification testing was conducted, and results demonstrated that testing results were found acceptable for software release. Software testing was performed per FDA's guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
Bench Testing: A system verification and validation of the Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System was conducted to confirm that the specifications match that of the predicate device. The testing results were found acceptable.
Clinical Testing
Based on the similarities of the device specifications, intended use, indications for use, treatment guidelines between the Nobleen Long Pulsed Alexandrite & Nd: Y A G Laser System and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification.
8. SUBSTANTIAL EQUIVALENCE
The Nobleen Long Pulsed Alexandrite & Nd: Y AG Laser System has the same intended uses. utilizes similar operating principles, and matches key design aspects, including similar spot size, the same wavelengths and the same maximum delivered energy as the predicate device. The nonclinical tests that were performed determined that Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System device is as safe, as effective, and performs as well as the predicate device. On the basis of similarities in methods of assembly, method of operation, and intended uses, as confirmed by the performance testing, FineMEC believes that the Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System is substantially equivalent to the predicate device.
9. CONCLUSION
The performance testing data demonstrates that Nobleen Long Pulsed Alexandrite & Nd: Y AG Laser System is as safe and effective as the legally marketed predicate devices. Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System did not raise new questions of safety or effectiveness. Therefore, based on the information provided in this Premarket Notification, we conclude that Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System has demonstrated substantial equivalence to the predicate devices.
§ 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.