(180 days)
Not Found
No
The device description focuses on traditional laser technology and control via a microprocessor and GUI, with no mention of AI or ML.
Yes
The device is intended for the treatment of various medical conditions, including vascular lesions and pigmented lesions, which falls under the definition of therapeutic intervention.
No
The device description and intended use indicate that the Helios II® laser system is used for various treatments, such as removal of hair, tattoos, and lesions, which are interventional procedures, not diagnostic ones.
No
The device description clearly outlines hardware components such as a Nd:YAG crystal, resonator, lamp, and high-pressure power source, indicating it is a physical laser system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a laser system used for direct treatment of soft tissue, hair, tattoos, vascular lesions, and pigmented lesions. It works by applying laser energy to the body.
- Lack of Sample Analysis: There is no mention of the device analyzing any samples taken from the body. Its function is entirely external and therapeutic.
Therefore, the Helios II® laser system, as described, falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Helios II® Q-Switched Nd:YAG Laser System delivers continuous wave laser light in the contact or non-contact mode for;
-
Tattoo Removal
- dark ink: blue and black
- light ink: red
- light ink: sky blue
- light ink: green
-
Treatment of Vascular Lesions:
- port wine birthmarks
- telangiectasias
- spider angioma
- cherry angioma
- spider nevi
-
Treatment of Pigmented Lesions:
- café-au-lait birthmarks
- solar lentiginos
- senile lentiginos
- becker's nevi
- freckles
- nevus spilus
- nevus of ota
Incision, excision, ablation, vaporization of soft tissue for general dermatology.
Removal or lightening of unwanted hair with or without adjuvant preparation.
Product codes
GEX
Device Description
The Helios II® laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. Three basic elements of operations are as follows:
-
A Nd:YAG crystal is used as a gain medium which produces a laser beam.
-
A resonator then amplifies the beam.
-
A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Nd:YAG crystal - a gain medium - and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit.
The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue for general dermatology.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Helios II® Q-Switched Nd:YAG Laser System is substantially equivalent to other existing systems in commercial distribution for treatment of the intended use indication as listed above and share very similar / exactly same performance specification parameters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(K) Summary - K083203
| Applicant: | Laseroptek Co. Ltd. |
|---|---|
| Address: | 204 Hyundai I Valley |
| 223-12 Sangdaiwon, Jungwon | |
| Sungnam, Kyunggi 462-714 | |
| South Korea | |
| Contact Person: | Dr. Hong Chu (President) |
| Telephone / Fax / E-mail: | Tel) 82.31.737.9885~8 |
| Fax) 82.31.737.9889 | |
| E-mail) hchu@laseroptek.com | |
| Submitter: | DPS International |
| Address: | 22750 Hawthorne Blvd., Suite 211 |
| Torrance, CA 90505 | |
| Contact Person: | Kevin J. Choi |
| Telephone / Fax / E-Mail: | Tel) 310.634.4480 |
| Fax) 310.378.8186 | |
| E-mail) kjchoil 128@hotmail.com | |
| Preparation Date: | August 16, 2008 |
| Device Trade Name: | Helios II® Q-Switched Nd:YAG Laser System |
| Common Name: | Nd:YAG Pulsed Surgical Laser |
| Classification Name: | Instrument, Surgical, Powered laser, 79-GEX, 21 |
| CFR 878-4810 |
Helios II® Q-Switched Nd:YAG Laser System
1
Los 3203 p-2
510(K) Summary - K083203
Helios II® Q-Switched Nd:YAG Laser System
| Legally Marketed Predicate Devices: | Fotona QX Nd:VAG/KTP Laser System,
K053139, by Fotona d.d.Medlite C3 Q Switched Nd:YAG Laser,
K011677, by Continuum Electro-Optics, Inc
(now Hoya CouiBio, Inc)Medlite C6 Q Switched Nd:YAG Laser,
K014234, by Continuum Electro-Optics, Inc
(now Hoya CouiBio, Inc) |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description of the Helios II® Q-
Switched Nd:YAG Laser System: | The Helios II® laser system is based on the Nd:YAG
(1064 nm) and frequency doubled KTP Nd:YAG
(532 nm) laser technology. Three basic elements of
operations are as follows:
-
A Nd:YAG crystal is used as a gain medium
which produces a laser beam. -
A resonator then amplifies the beam.
-
A lamp that contains Xe gas is used, as a
pumping light source. The lamp requires a
high-pressure power source device for
operation. When the electric energy
generated from the high-pressure power
source is induced into the electrode of the
lamp, it converts into light energy. This
converted light energy pumps the Nd:YAG
crystal - a gain medium - and the light
exhausted from the crystal is amplified into a
specific wavelength light. As it passes
between the resonant gases, laser beam
radiates to an output unit. |
The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.
2
510(K) Summary - K083203
Helios II® Q-Switched Nd:YAG Laser System
Intended Use of the Helios II® Q-Switched Nd:YAG Laser System:
The Helios II® Q-Switched Nd:YAG Laser System delivers continuous wave laser light in the contact or non-contact mode for;
· Tattoo Removal
- dark ink: blue and black
- · light ink: red
- light ink: sky blue
- · light ink: green
Treatment of Vascular Lesions:
- port wine birthmarks
- · telangiectasias
- · spider angioma
- · cherry angioma
- · spider nevi
Treatment of Pigmented Lesions:
- · café-au-lait birthmarks
- · solar lentiginos
- · senile lentiginos
- · becker's nevi
- freckles
- nevus spilus
- · nevus of ota
None
Performance Data:
Conclusion:
The Helios II® Q-Switched Nd:YAG Laser System is substantially equivalent to other existing systems in commercial distribution for treatment of the intended use indication as listed above and share very similar / exactly same performance specification parameters.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2009
Laseroptek Co. Ltd. % DPS International Mr. Kevin J. Choi 22750 Hawthorne Boulevard #211 Torrance, California 90505
Received: April 22, 2009
Re: K083203
Trade/Device Name: Helios II Q-Switched 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: II Product Code: GEX Dated: April 20, 2009
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 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 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.
4
Page 2 - Mr. Kevin J. Choi
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. N. elkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K083203 p. lot 1
Indications for Use
510(k) Number (if known):
Device Name:
Helios II Q-Switched ND:YAG Laser System
Indications For Use:
Incision, excision, ablation, vaporization of soft tissue for general dermatology.
Removal or lightening of unwanted hair with or without adjuvant preparation.
Tattoo Removal
- dark ink: blue and black .
- light ink. red
- light ink: sky blue
- light ink: green
Treatment of Vascular Lesions:
- port wine birthmarks
- telangiectasias .
- spider angioma
- cherry angioma .
- spider nevi
Treatment of Pigmented Lesions:
- café-au-lait birthmarks .
- solar lentiginos .
- senile lentiginos .
- becker's nevi
- freckles
- nevus spilus
- nevus of ota
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 ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AND/OR
age 1 of 1
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K083203