(183 days)
Not Found
No
The summary describes a laser system with standard components and functions, with no mention of AI or ML capabilities.
Yes
The device is intended for the treatment of various medical conditions such as wrinkles, pseudofolliculitis barbae (PFB), and vascular lesions, as well as surgical procedures like excision and vaporization of soft tissue.
No
The "Intended Use / Indications for Use" section specifies various treatments such as wrinkle treatment, hair removal, and soft tissue procedures, all of which are therapeutic rather than diagnostic. A diagnostic device would be used to identify a condition or disease.
No
The device description explicitly states that Hyperion is a laser system consisting of a main cabinet, optical fiber with hand pieces, and a footswitch, all of which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Hyperion's Function: The description clearly states that Hyperion is a laser system used for various dermatological treatments performed on the body (in vivo). It uses laser energy to interact directly with tissues for purposes like hair removal, wrinkle treatment, and soft tissue procedures.
The intended use and device description focus entirely on therapeutic and surgical applications performed directly on the patient, not on analyzing biological samples in a lab setting.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical testing of Hyperion 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Valley |
| 223-12 Sangdaiwon, Jungwon | |
| Sungnam-Si, Gyeonggido, 462-714 | |
| Rep. of Korea (South Korea) | |
| Contact Person: | Hong Chu, Ph.D. (President & CEO) |
| Telephone / Fax / E-mail: | Tel) +82.31.737.9885 |
| E-mail) hchu@laseroptek.com | |
| Submitter: | Scarlet RF, Inc. |
| Address: | 17145 Von Karman Ave, Suite 106 |
| Irvine, CA 92614, USA | |
| Contact Person: | Kevin J. Choi |
| Telephone / Fax / E-Mail: | Tel) 310-634-4480 |
| E-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) .
1
| Intended Use of Hyperion: | 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 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | 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. |
| Performance Data: | Non-clinical testing of Hyperion 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. |
| Substantial Equivalence
(Intended Use) | Hyperion's intended use is identical to the intended use of the
predicate devices: Candela's Gentle YAG Laser System, Fotona's
XP Nd:YAG Laser System, and Cynosure's Apogee Elite Laser |
| Substantial Equivalence
(Technical) | Hyperion is based on the Nd:YAG (1064 nm) laser technology as
its predicated devices listed above. Hyperion long pulsed
Nd:YAG laser operates in a similar fashion as its predicate
devices, with the same principle of operation, the same
wavelength (1064 nm) and essentially the same power range and
the same indications for uses. |
| | Based upon analysis of the overall performance characteristic for
the device, Laseroptek Co. Ltd. believes that no significant
differences exist between Hyperion and its predicate devices.
Therefore, Hyperion should not raise new safety or effectiveness
issues. |
2
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
3
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
4
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)
Image /page/4/Picture/17 description: The image shows the name "Neil R Ogden" followed by "-S". Below that is the date "2014.01.21" and the time "13:56:37". To the right of the time is a logo that is difficult to make out. The logo appears to have the numbers "05:00" in it.
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.