(206 days)
Not Found
No
The summary describes a laser system for tattoo and lesion removal, focusing on hardware components and performance against standards. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is described as a laser system for "Tattoo Removal" and "Treatment of Pigmented Lesions," which are medical procedures aimed at treating or alleviating a condition, thus making it a therapeutic device.
No
The device is described as a laser system used for tattoo removal and treatment of pigmented lesions. Its function is to perform a procedure, not to diagnose a condition.
No
The device description explicitly lists multiple hardware components including a control system, power supplier, cooling system, laser generator, articulated arm, and foot switch.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for tattoo removal and treatment of pigmented lesions on the skin. These are procedures performed directly on a patient's body.
- Device Description: The device is a laser system with an articulated arm and foot switch, designed to deliver laser energy to the skin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to analyze samples taken from the human body to provide diagnostic information. This device is a therapeutic laser system used for cosmetic and dermatological treatments.
N/A
Intended Use / Indications for Use
1064 nm wavelength: Tattoo Removal (Dark Ink, Black & Blue ) .Ota's nevus
532 nm wavelength: Tattoo Removal (Light Ink. Red, Sky Blue and Green) Treatment of Pigmented Lesions Solar Lentiginos Senile Lentiginos
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The proposed device includes three models as YILIYA- 1064QCH, YILIYA- 1064QCL and Aeslight-1064QEH, the differences between three models described in the subsection 5 specification. The proposed device is the laser system with modularization and multi-wavelength, includes the waveform as 1064 nm and 532 nm.
The proposed device consisted by control system, power supplier, cooling system, laser generator, articulated arm and foot switch.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; a) Amendment 1, 1991-11, Amendment 2, 1995.
- IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2: General Requirements for b) Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
- IEC 60601-2-22 (1995) Medical Electrical Equipment Part 2: Particular requirements for c) the safety of diagnostic and therapeutic.
- IEC 60825-: 2007 Safety of laser products Part 1: Equipment classification and requirements d)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Exhibit #4 510(k) Summary
Project #:M0272013Bd
1 6 2014 JAN
Exhibit #4 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________
- Date of Prepared: 01/11/2014 1.
-
- Sponsor
Beijing Honkon Technologies Co., Ltd. No.3 Building, No.11 Yard, Kangding Street, BDA, 100176,Beijing, P.R.China
Establishment Registration Number: Not yet registered
Contact Person: Li Zhao Position: Management Representative Tel: +86 10 56370050 ext. 508 Fax: +86 10 56370067 ext. 610 Email: small@honkonlaser.com
- Submission Correspondent 3.
Diana Hong & Tarzan. Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
1
- नं Proposed Device Identification
Proposed Device Name: Q-Switched ND: YAG Laser Device Common Name: Laser Device Proposed Device Model: YILIYA- 1064QCH, YILIYA- 1064QCL, Aeslight- 1064QEH
Classification: Classification Name: powered laser surgical instrument Classification: 11; Product Code: GEX: Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;
Intended Use Statement:
1064 nm wavelength:
Tattoo Removal (Dark Ink, Black & Blue )
Ota's nevus
532 nm wavelength:
Tattoo Removal (Light Ink, Red, Sky Blue and Green)
Treatment of Pigmented Lesions
Solar Lentiginos
Senile Lentiginos
- Predicate Device Identification
510(k) Number: K063834 Product Name: RevLite™ Q-Switched Nd: YAG Laser System Manufacturer: Hoya ConBio, Inc.
Device Description 6.
.
The proposed device includes three models as YILIYA- 1064QCH, YILIYA- 1064QCL and Aeslight-1064QEH, the differences between three models described in the subsection 5 specification. The proposed device is the laser system with modularization and multi-wavelength, includes the
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2
waveform as 1064 nm and 532 nm.
The proposed device consisted by control system, power supplier, cooling system, laser generator, articulated arm and foot switch.
-
- Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; a) Amendment 1, 1991-11, Amendment 2, 1995.
-
IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2: General Requirements for b) Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
-
IEC 60601-2-22 (1995) Medical Electrical Equipment Part 2: Particular requirements for c) the safety of diagnostic and therapeutic.
-
IEC 60825-: 2007 Safety of laser products Part 1: Equipment classification and requirements d)
-
- Technological Characteristics Comparison
The proposed device has the same technological characteristics with the predicate device, such as Laser Medium, wavelength, control method and intended use.
-
- Substantially Equivalent Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
- Substantially Equivalent Conclusion
| ITEM | Proposed Device | Predicate Device K063834 | ||||
|---|---|---|---|---|---|---|
| Product Name | YILIYA- | YILIYA- | Aeslight- | RevLite™ Q-Switched Nd: YAG | ||
| 1064QCH | 1064QCL | 1064QEH | Laser System | |||
| Laser Medium | Nd: YAG | Nd: YAG | ||||
| wavelength | 1064 nm | 1064 nm | ||||
| 532 nm | 532 nm | |||||
| Output energy | 800 mJ at max. | 1600 mJ @ 1064 nm | ||||
| 500 mJ @ 532 nm | ||||||
| Energy | ||||||
| Max. | ||||||
| Density | 25.47J/cm2 at max. | 22.64J/cm2 | ||||
| Spot Size | 2-7 mm | 3. 4. 6& 8 mm (a) 1064 nm | ||||
| 2, 3, 4 & 6 mm (a,532 nm | ||||||
| Pulse Width | 6-10 ns | 5-20 ns |
| Table III-1 | Comparison Table | ||
|---|---|---|---|
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| Repetition Rate | 1-10 Hz | 1, 2, 5, 10 Hz |
|---|---|---|
| Power | ||
| calibration | The device is calibrated by laser | |
| energy/power meter no less than 1 | ||
| time each year | --- | |
| Laser Class | Class 4 | Class 4 |
| Aiming Beam | A focusing device (viewfinder) fitted | |
| on the end instead of aiming beam | ||
| And | ||
| A red aiming beam for 1064 QEH | Red Aiming Beam |
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Beijing Honkon Technologies Company, Ltd. % Ms. Diana Hong Mid-Link Consulting Company, Ltd P.O. Box 120-119 Shanghai, 200120 CHINA
January 16, 2014
Re: K131857
· Trade/Device Name: YILIYA-1064QCH, YILIYA-1064QCL, and Aeslight-1064QEH 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 2, 2013 Received: December 6, 2013
Dear Ms. Hong:
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
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Page 2 - Ms. Diana Hong
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.
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 C. Nipper -S
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131857
Device Name YILIYA- 1064QCH, YILIYA- 1064QCL, Aeslight- 1064QEH
Indications for Use (Describe) 1064 nm wavelength: Tattoo Removal (Dark Ink, Black & Blue ) .Ota's nevus
532 nm wavelength: Tattoo Removal (Light Ink. Red, Sky Blue and Green) Treatment of Pigmented Lesions Solar Lentiginos Senile Lentiginos
Type of Use (Select one or both, as applicable)
[x] 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.
FOR FOR FOR FOR FOR FOR FOR FOR USE ONLY - CHE CHARLES - CHEAR - CHEAR
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/6/Picture/12 description: The image shows the name "Neil R Ogden -S" in bold black font on the top line. The second line shows the date and time "2014.01.14 16:15" also in bold black font. To the right of the name is a faded logo that is difficult to make out.
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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