(183 days)
Hyperion is a long pulsed Nd:YAG laser intended for treatment of wrinkles, Removal of unwanted hair for stable long term or *permanent hair reduction, treatment of pseudofolliculitis barbae (PFB), surgical incision, excision, vaporization, ablation and coagulation of soft tissue, and photocoagulation and hemostasis of pigmented and vascular lesions in dermatology. *Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-grown when measured at 6, 9, and 12 months after the completion of a treatment regimen
Hyperion is a long pulse Nd:YAG laser system that produces laser emission at the wavelength of 1064nm. The system consists of three interconnected sections: a) the main cabinet, which houses the power supply, cooling system, microprocessor, and the laser generator, b) the optical fiber with hand pieces which can be used selectively depending on the size of the laser beam exposure, c) the footswitch.
This document describes the 510(k) summary for the Hyperion Long Pulsed Nd:YAG Laser. It indicates that the device's substantial equivalence is based on its similarity to predicate devices, rather than on new performance data from a specific study directly proving its acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Device Feature/Criterion | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Hyperion) |
|---|---|---|
| Intended Use | Identical to predicate devices (Candela's Gentle YAG Laser System, Fotona's XP Nd:YAG Laser System, and Cynosure's Apogee Elite Laser) | Hyperion is intended for treatment of wrinkles, removal of unwanted hair for stable long-term or permanent hair reduction, treatment of pseudofolliculitis barbae (PFB), surgical incision, excision, vaporization, ablation and coagulation of soft tissue, and photocoagulation and hemostasis of pigmented and vascular lesions in dermatology. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-grown when measured at 6, 9, and 12 months after the completion of a treatment regimen. |
| Technology | Nd:YAG (1064 nm) laser technology, as per predicate devices. | Hyperion is based on Nd:YAG (1064 nm) laser technology. |
| Principle of Operation | Similar to predicate devices. | Hyperion operates in a similar fashion as its predicate devices. |
| Wavelength | 1064 nm, same as predicate devices. | 1064 nm. |
| Power Range | Essentially the same as predicate devices. | Essentially the same power range as predicate devices. |
| Indications for Use | Same as predicate devices. | Same indications for uses as predicate devices. |
| Safety | Compliance with IEC 60601-1 and 60601-1-2 standards and general safety considerations for similar devices. | Non-clinical testing included visual and mechanical inspection, electrical and mechanical safety testing, software testing, etc., in bench. Electrical testing was performed in accordance with IEC 60601-1 and 60601-1-2 standards. |
| Effectiveness | Demonstrated effectiveness for intended uses, as established by predicate devices. | Laseroptek Co. Ltd. believes that no significant differences exist between Hyperion and its predicate devices, implying equivalent effectiveness. |
The Study Proving the Device Meets Acceptance Criteria
The provided document does not describe a performance study with acceptance criteria in the traditional sense of a clinical trial demonstrating efficacy against specific endpoints. Instead, the "study" for proving acceptance relies on demonstrating Substantial Equivalence to legally marketed predicate devices.
The justification for the Hyperion Long Pulsed Nd:YAG Laser meeting acceptance criteria is based on the following:
- Non-clinical testing: This included visual and mechanical inspection, electrical and mechanical safety testing, and software testing in a bench environment.
- Compliance with standards: Electrical testing was performed in accordance with IEC 60601-1 and 60601-1-2 standards.
- Comparison to predicate devices: The core argument is that the Hyperion device has the same intended use, utilizes the same underlying technology (Nd:YAG laser at 1064nm), operates on the same principle, and has essentially the same power range and indications for use as the legally marketed predicate devices:
The submission concludes that, based on this analysis, no significant differences exist between Hyperion and its predicate devices, and therefore, it should not raise new safety or effectiveness issues.
Specific Information Requested (Based on the document):
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The document does not describe a clinical "test set" for a performance study. The evaluation is based on non-clinical bench testing and comparison to existing predicate devices.
-
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):
- N/A. As no clinical test set with a ground truth determination is described.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. As no clinical test set requiring adjudication is described.
-
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:
- N/A. This device is a laser system, not an AI-assisted diagnostic or therapeutic device requiring a MRMC study.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This device is a medical laser, not an algorithm. Bench testing for safety and operational parameters was performed.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. The "ground truth" for demonstrating substantial equivalence rests on the established safety and effectiveness of the predicate devices for their indicated uses, which would have been based on their own clinical evidence at the time of their clearance. For the Hyperion itself, the "ground truth" for its acceptance criteria is compliance with engineering standards and direct comparison of its technical specifications and intended uses to the predicate devices.
-
The sample size for the training set:
- N/A. The device is a laser, not a machine learning model, so there is no training set in this context.
-
How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set.
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Section 4 510(k) Summary Statement Hyperion Long Pulsed Nd:YAG Laser
.
Section 4 - This 510(k) Summary of safety and effectiveness is submitted in accordance with the requirements of 21 CFR §807.92
| Submitter's Information | |
|---|---|
| Applicant: | Laseroptek Co. Ltd. |
| Address: | 204 Hyundai I Valley223-12 Sangdaiwon, JungwonSungnam-Si, Gyeonggido, 462-714Rep. of Korea (South Korea) |
| Contact Person: | Hong Chu, Ph.D. (President & CEO) |
| Telephone / Fax / E-mail: | Tel) +82.31.737.9885E-mail) hchu@laseroptek.com |
| Submitter: | Scarlet RF, Inc. |
| Address: | 17145 Von Karman Ave, Suite 106Irvine, CA 92614, USA |
| Contact Person: | Kevin J. Choi |
| Telephone / Fax / E-Mail: | Tel) 310-634-4480E-mail) kjychoi@gmail.com |
| Preparation Date: | 04/22/2013 |
| Device Trade Name: | Hyperion |
| Common Name: | Long Pulsed Nd:YAG Dermatological Laser |
| Classification Name: | Instruments, Surgical, Powered, Laser 79-GEX(21 CFR §878-4810) |
| Legally Marketed Predicate Devices: | Candela, Inc. - Gentle YAG Laser System(K022951)Fotona d.d. - XP Nd:YAG Laser System(K090126) |
- Cynosure, Inc. Apogee Elite Laser (K034030) .
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| Intended Use of Hyperion: | Hyperion is a long pulsed Nd:YAG laser intended for treatmentof wrinkles, Removal of unwanted hair for stable long term or*permanent hair reduction, treatment of pseudofolliculitis barbae(PFB), surgical incision, excision, vaporization, ablation andcoagulation of soft tissue, and photocoagulation and hemostasisof pigmented and vascular lesions in dermatology. *Permanenthair reduction is defined as the long-term stable reduction in thenumber of hairs re-grown when measured at 6, 9, and 12 monthsafter the completion of a treatment regimen |
|---|---|
| Device Description: | Hyperion is a long pulse Nd:YAG laser system that produceslaser emission at the wavelength of 1064nm. The system consistsof three interconnected sections: a) the main cabinet, whichhouses the power supply, cooling system, microprocessor, andthe laser generator, b) the optical fiber with hand pieces whichcan be used selectively depending on the size of the laser beamexposure, c) the footswitch. |
| Performance Data: | Non-clinical testing of Hyperion included visual and mechanicalinspection, electrical and mechanical safety testing, softwaretesting, etc., in bench. Electrical testing was performed inaccordance with IEC 60601-1 and 60601-1-2 standards. |
| Substantial Equivalence(Intended Use) | Hyperion's intended use is identical to the intended use of thepredicate devices: Candela's Gentle YAG Laser System, Fotona'sXP Nd:YAG Laser System, and Cynosure's Apogee Elite Laser |
| Substantial Equivalence(Technical) | Hyperion is based on the Nd:YAG (1064 nm) laser technology asits predicated devices listed above. Hyperion long pulsedNd:YAG laser operates in a similar fashion as its predicatedevices, with the same principle of operation, the samewavelength (1064 nm) and essentially the same power range andthe same indications for uses. |
| Based upon analysis of the overall performance characteristic forthe device, Laseroptek Co. Ltd. believes that no significantdifferences exist between Hyperion and its predicate devices.Therefore, Hyperion should not raise new safety or effectivenessissues. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three stylized wing or feather shapes.
Public Health Service
Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
Laseroptek Company, Ltd % Mr. Kevin J. Choi Scarlet RF Incorporated 28 Stafford Drive West Windsor, New Jersey 08550
January 22, 2014
Re: K132286
Trade/Device Name: Hyperion Long Pulse Nd: YAG Laser 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: December 24, 2013 Received: December 27, 2013
Dear Mr. Choi:
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 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
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Page 2 - Mr. Kevin J. Choi
device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Joshua
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132286
Device Name Hyperion Long Pulse Nd: YAG Laser
Indications for Use (Describe)
Treatment of wrinkles
Removal of unwanted hair for stable long term or *permanent hair reduction
Treatment of PFB (pseudofolliculitis barbae)
Surgical incision, excision vaporization, ablation and coagulation of soft tissue
Photocoagulation and hemostasis of pigmented and vascular lesions in dermatology
*Permanent hair reduction is defined as the long-term stable reduction in the number of hair re-grown when measured at 6, 9, and 12 months after the completion of a treatment regimen.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
The proportion of the FOR FDA USE ONLY CONTRACT AND A PARTY CHANGE OF SCHOOL
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
PSC Publishing Services (301) 443-6740
FI
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
§ 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.