(91 days)
Not Found
No
The description focuses on the laser technology and its wavelengths for various dermatological treatments. There is no mention of AI or ML in the intended use, device description, or any other section.
Yes
The device is described as a laser system intended for medical procedures like incision, excision, ablation, and vaporization of soft tissue, as well as removal or treatment of various lesions and tattoos, which are therapeutic interventions.
No
The "Intended Use" section explicitly states that the device is for "INCISION, EXCISION, ABLATION, AND VAPORIZATION OF SOFT TISSUE" and for "REMOVAL" or "TREATMENT" of various lesions and tattoos. These are all therapeutic or cosmetic procedures, not diagnostic ones.
No
The device description explicitly states it is a "Nd: YAG LASER SYSTEM" and describes hardware components like emitted wavelengths, a frequency doubler, and a handpiece that delivers energy to the skin. This indicates it is a hardware device, 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 devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that this device is a laser system used for direct treatment of soft tissue and skin lesions through incision, excision, ablation, and vaporization. It delivers energy directly to the body.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any specimens from the body. The device acts directly on the patient's tissue.
Therefore, this device falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- FOR INCISION, EXCISION, ABLATION, AND VAPORIZATION OF SOFT TISSUE FOR GENERAL DERMATOLOGY.
- THE 1064 NM WAVELENGTH IS INDICATED FOR: DARK INK TATTOO REMOVAL TREATMENT OF PIGMENTED LESIONS SUCH AS NEVUS OF OTA. REMOVAL OR LIGHTENING OF HAIR. TREATMENT OF COMMON NEVI
- THE 532 NM WAVELENGTH IS INDICATED FOR: REMOVAL OF LIGHT INK (RED, TAN, PURPLE, AND ORANGE) TATTOOS TREATMENT OF COMMON NEVI TREATMENT OF CAFÉ AU-LAIT SPOTS. TREATMENT OF SEBORRHEIC KERATOSES TREATMENT OF VASCULAR LESIONS, INCLUDING FACIAL AND LEG VEINS, TELENGIECTASIAS, ANGIOMAS, HEMANGIOMAS, PORT-WINE STAINS, AND MOST PICMENTED LESINS SUCH AS LENTIGINES, AND EPHELIDES.
MINI-YAG LASER SYSTEM FROM AMERICAN LASERS, INC. IS A SOLID STATE Nd YAG LASER SYSTEM THAT PROVIDES TWO WAVELENGTHS, 1064nm AND 532nm FOR THE REMOVAL OF BLACK AND BLUE TATTOOS AS WELL AS SUPERFICIAL EPIDERMAL PIGMENTED LESIONS AND SMALL VASCULAR LESIONS.
TATTOOS REMOVAL: THE 532nm WAVELENGTH CAN BE USED TO REMOVE RED, TAN, PURPLE, AND ORANGE TATTOO INKS. THE 1064mm WAVELENGTH CAN BE USED TO REMOVE DARK (BLACK) AND BLUE COLOR INKS.
THE 532nm WAVELENGTH CAN ALSO BE USED FOR REMOVAL OF SUPERFICIAL BENIGN, PIGMENTED SKIN LESIONS SUCH AS LENTIGINES AND CAFÉ-AU-LAIT, TREATMENT OF COMMON NEVI, AND SEBORRHEIC KERATOSES. ALSO THE 532nm WAVELENGTH CAN BE USED TO REMOVE SMALL VASCULAR LESIONS SUCH AS TELANGIECTASIAS, SMALL FACIAL AND LEG VEINS, ANGIOMAS, HEMANGIOMAS, PORT-WINE STAINS, AND MOST OTHER BENIGN PIGMENTED LESIONS SUCH AS LENTIGINES AND EPHELIDES. THE 1064mm WAVELENGTH CAN ALSO BE USED TO TREAT PIGMENTED LESIONS SUCH AS THE NEVUS OF OTA, REMOVAL OR LIGHTENING OF HAIR, TREATMENT OF COMMON NEVI.
Product codes
GEX
Device Description
THE MINI_YAG LASER IS A Nd: YAG LASER WITH EMITTED WAVELENGTH AT 1064 NANOMETERS. WITH THE FREQUENCY DOUBLER INSTALLED, A 532 NANOMETER WAVELENGTH IS EMITTED. THE 1064 NM IS IN THE NEAR-INFRARED PORTION OF THE SPECTRUM, WHILE THE 532 NM IS VISIBLE AS A GREEN LIGHT, LASER ENERGY IS DELIVERED DIRECTLY TO THE SKIN LESION VIA THE HANDPIECE, WHICH PRODUCES A CIRCULAR BEAM ON THE SKIN. THE MINI-YAG LASER IS EQUIPPED WITH SAFETY FEATURES IN CONFORMANCE WITH 21CFR PART 1040.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, Facial, Leg
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K023967, K022709, K983054, K011677, K014234, K000317, K033259
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
AMERICAN LASERS, INC.
K061850
SEP 2 9 2006
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS MINI-YAG LASER
IN ACCORADANCE WITH THE SAKE MEDICAL DEVICES ACT OF 1990, 21CFR 807,92, THE FOLLOWING IS A SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION ON WHICH THE SUBSTANTIAL EQUIVALENCE DETERMINATION IS BASED.
THE SAFETY AND EFFECTIVENESS OF THE MINI-VAG LASER DERIVES FROM A DETERMINATION OF SUBSTANTIAL EQUIVALENCE TO THE PREDICATE DEVICES LISTED BELOW.
AMERICAN LASERS, INC. APPLICANT: 300 EAST MAIN STREET ALHAMBRA, CA 91801 C/O DAVID K. QUON, PRESIDENT
DATE PREPARED: SEPTEMBER 22, 2006
MODEL:
TRADE NAME: MINI-YAG LASER COMMON NAME: Q-SWITCHED Nd: YAG LASER WITH FREQUENCY DOUBLER.
PRODUCT CODE: GEX
PANEL: 79
C.F.R. SECTION: 878.4810
CLASSIFICATION PANEL: GENERAL AND PLASTIC SURGERY.
CLASSIFICATION: MEDICAL DEVICE CLASS: REGULATORY CLASS II LASER SAFETY CLASS: CLASS IV LASER PRODUCT
PREDICATE DEVICES:
PALOMAR Q-YAG LASER SYSTEM (K023967) MEDLITE Q-SWITCHED Nd: YAG LASER (K022709 & K983054) MEDLITE C3 Q-SWITCHED Nd: Y AG LASER (K011677) MEDLITE C6 Q-SWITCHED Nd: YAG LASER (K014234) SPECTRA-VRM Q-SWITCHED Nd:YAG LASER (K000317) LIGHT AGE Q-CLEAR LASER (K033259)
DESCRIPTION:
THE MINI_YAG LASER IS A Nd: YAG LASER WITH EMITTED WAVELENGTH AT 1064 NANOMETERS. WITH THE FREQUENCY DOUBLER INSTALLED, A 532 NANOMETER WAVELENGTH IS EMITTED. THE 1064 NM IS IN THE NEAR-INFRARED PORTION OF THE SPECTRUM, WHILE THE 532 NM IS VISIBLE AS A GREEN LIGHT, LASER ENERGY IS DELIVERED DIRECTLY TO THE SKIN LESION VIA THE HANDPIECE, WHICH PRODUCES A CIRCULAR BEAM ON THE SKIN. THE MINI-YAG LASER IS EQUIPPED WITH SAFETY FEATURES IN CONFORMANCE WITH 21CFR PART 1040.
1
INTENDED USES:
- FOR INCISION, EXCISION, ABLATION, AND VAPORIZATION OF SOFT TISSUE FOR 1. GENERAL DERMATOLOGY.
- THE 1064 NM WAVELENGTH IS INDICATED FOR: 2. DARK INK TATTOO REMOVAL TREATMENT OF PIGMENTED LESIONS SUCH AS NEVUS OF OTA. REMOVAL OR LIGHTENING OF HAIR. TREATMENT OF COMMON NEVL
- THE 532 NM WAVELENGTH IS INDICATED FOR: 3. REMOVAL OF LIGHT INK (RED, TAN, PURPLE, AND ORANGE) TATTOOS TREATMENT OF COMMON NEVI TREATMENT OF CAFÉ AU-LAIT SPOTS. TREATMENT OF SEBORRHEIC KERATOSES TREATMENT OF VASCULAR LESIONS, INCLUDING FACIAL AND LEG VEINS, TELENGIECTASIAS, ANGIOMAS, HEMANGIOMAS, PORT-WINE STAINS, AND MOST PICMENTED LESINS SUCH AS LENTIGINES, AND EPHELIDES.
SAFETY AND EFFECTIVENESS:
THE MINI-YAG LASER FROM AMERICAN LASERS, INC. HAS THE SAME WAVELENGTHS, THE SAME SPOT SIZE, THE SAME PRINCIPLE OF OPERATION, ESSENTIALLY THE SAME FLUENCE LEVELS, AND THE SAME INTENDED USE AS THE PREDICATE DEVICES. THE MINI-YAG LASER DOES NOT RAISE NEW QUESTIONS OF SAFETY OR EFFECTIVENESS, AND IS SUBSTANTIALLY EQUIVALENT TO THE PREDICATE DEVICES LISTED ABOVE.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. 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
SEP 2 9 2006
American Lasers, Inc. % Mr. David K. Quon, MD President 300 East Main Street Alhambra, California 91801
Re: K061850
Trade/Device Name: Mini-Yag 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: June 28, 2006 Received: July 31, 2006
Dear Dr. Quon:
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 referented 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n 70ar are level to such 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); 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.
3
Page 2 -- Mr. David K. Quon, MD
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Rar
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KORT 850 510(k) Number (if known):
MINI-YAG Device Name:
. Indications For Use: - HERMINGLASER SYSTEM FROMAAMERICAN LASERS, INC. IS A SQLD STATE . Nd YAG LASER SYSTEM THAT PROVIDES TWO WAVELENGTHS, 1064nm AND 532nm FOR THE REMOVAL OF BLACK AND BLUE TATTOOS AS WELL AS SUPERFICIAL EPIDERMAL PIGMENTED LESIONS AND SMALL VASCULAR LESIONS.
TATTOOS REMOVAL: THE 532nm WAVELENGTH CAN BE USED TO REMOVE RED, TAN, PURPLE, AND ORANGE TATTOO INKS. THE 1064mm WAVELENGTH CAN BE USED TO REMOVE DARK (BLACK) AND
BLUE COLOR INKS.
THE 532um WAVELENCIA CAN ALSO BLE USED POR REMOVAL OF SUPERIACAL BENIGN, PIGMENTED SKIN LESIONS SUCH AS LENTIGINES AND CAFE-AU-LAIT, TREATMENT OF COMMON NEVI, AND SEBORRHEIC KERATOSES. ALSO THE 532am WAVELENGTH CAN BE USED TO REMOVE SMALL VASCULAR LESIONS SUCH AS TELAGIECTASIAS, SMALL FACIAL AND LEG VEINS, ANGIOMAS, HEMANGIOMAS, PORT-WINE STAINS, AND MOST OTHER BENIGN PIGMENTED LESIONS SUCH AS LENTIGINES AND EPHELIDES. THE 1064mm WAVFI.ENGTH CAN ALSO RE USED TO TREAT PIGMENTED LESIONS SUCH AS THE NEVUS OF OTA, REMOVAL OR LIGHTENING OF HAIR, TREATMENT OF COMMON NEVI.
XX -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)
AND/OR
| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | Page 1 of |
510(k) Number L021850