(36 days)
No
The provided text describes a laser system for hair removal and does not mention any AI or ML components or functionalities.
No
The device is intended for "cosmetic removal of unwanted hair," which is not considered a therapeutic use.
No
The intended use of the device is for the cosmetic removal of unwanted hair, which is a treatment rather than a diagnostic purpose.
No
The device description explicitly states it is a "medical device which is capable of emitting an invisible treatment laser beam" and mentions a "visible aiming beam," indicating it is a hardware device that emits light, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "cosmetic removal of unwanted hair on adults." This is a therapeutic or cosmetic procedure performed directly on the patient's body.
- Device Description: The device is a laser system that emits a laser beam. This is a physical intervention, not a test performed on biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This laser system does not fit that description.
N/A
Intended Use / Indications for Use
The SmoothLASE TM Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The SmoothLASE TM Alexandrite Laser System is intended for use only by qualified physicians trained in the safe operation of the system.
Product codes
GEX
Device Description
The SmoothLASE TM Alexandrite Laser System is a medical device which is capable of emitting an invisible treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. In addition to the standard pulse width of nominally 1 Msec at 1Hz, the SmoothLASE TM Alexandrite Laser System will operate up to 3 Hz. Additionally, a single pulse is modulated to provide 6 x 1 Msec pulses at 1.3 Hz.
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
adults (18 years or older)
Intended User / Care Setting
qualified physicians trained in the safe operation of the system.
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)
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
2/11/99
LEISEGANG MEDICAL, INC. 6401 CONGRESS AVENUE BOCA RATON, FLORIDA 33487-2883 (561) 994-0202 (800) 448-4450 FAX: (561) 998-0846
K 990043
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Date: | January 4, 1999 |
|---|---|
| Prepared By: | Loma K. Linville |
| Classification Name: | Instrument, surgical, powered, laser |
| 79-GEX | |
| 21 CFR 878.48, Class II | |
| Proprietary Name: | SmoothLASE TM Alexandrite Laser System |
| Indications: | The SmoothLASE TM Alexandrite Laser is intended for the |
| cosmetic removal of unwanted hair on adults (18 years or older). | |
| The SmoothLASE TM Alexandrite Laser System is intended for | |
| use only by qualified physicians trained in the safe operation of | |
| the system. | |
| Description: | The SmoothLASE TM Alexandrite Laser System is a medical |
| device which is capable of emitting an invisible treatment laser | |
| beam at a wavelength of 755 nm under the guidance of a visible | |
| aiming beam. In addition to the standard pulse width of nominally | |
| 1 Msec at 1Hz, the SmoothLASE TM Alexandrite Laser System | |
| will operate up to 3 Hz. Additionally, a single pulse is modulated | |
| to provide 6 x 1 Msec pulses at 1.3 Hz. | |
| Safety Features: | The safety features of the device have been designed in |
| accordance with relevant standards such as BS EN 60825-1 | |
| (Safety of Laser Product) and BS EN 6061-2-22 (Medical | |
| Electrical Equipment Safety). The labeling complies with 21 CFR | |
| subchapter J for a Class IV laser product. | |
| Predicate Devices: | The SmoothLASE TM Alexandrite Laser System is |
| substantially equivalent to numerous devices that are currently | |
| commercially available. These devices include the Cynosure | |
| PhotoGenica LPIR (K971737) and the Lambda LaseAway | |
| Alexandrite Laser distributed by Silver Creek Surgical (K982316). | |
| Conclusion: | The SmoothLASE TM Alexandrite Laser System is safe and |
| effective for the intended purpose of removal of unwanted body | |
| hair on adults 18 years of age or older. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with three lines representing its wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 1999
Mr. Rahn F. Smith Product Manager, Diagnostic Division Leisegang Medical, Inc. 6401 Congress Avenue Boca Raton, Florida 33487-2883
Re: K990043 Trade Name: SmoothLASE™ Alexandrite Laser System Regulatory Class: II Product Code: GEX Dated: January 4, 1999 Received: January 6, 1999
Dear Mr. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Rahn F. Smith
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1
510(k) Number (if Known): 上 9900 43
SmoothLASE Alexandrite Laser System Device Name:
Indications For Use:
1
The SmoothLASE Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The SmoothLASE Alexandrite Laser System is intended for use only by qualified physicians trained in the safe operation of the system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)