(90 days)
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No
The document describes a laser device and its intended uses, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is indicated for medical procedures such as tattoo removal, hair removal, and laser skin resurfacing, which are therapeutic interventions aimed at altering or improving body functions or structures.
No
The device is a laser system used for tattoo removal, hair removal, and skin resurfacing, which are therapeutic and cosmetic procedures, not diagnostic ones.
No
The device description explicitly states it consists of a "laser device and a beam-shrinking handpiece," which are hardware components.
Based on the provided information, the ThermoLase SoftLight Q-Switched Nd: YAG Laser 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 the ThermoLase SoftLight Q-Switched Nd: YAG Laser is a laser device used for:
- Tattoo removal/reduction.
- Hair removal/lightening (in combination with a topical lotion).
- Laser skin resurfacing.
- Mechanism of Action: The device works by applying laser energy directly to the skin or the substances within the skin (tattoo dyes, hair follicles). This is a direct interaction with the body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the ThermoLase SoftLight Q-Switched Nd: YAG Laser is a therapeutic and aesthetic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ThermoLase SoftLight Q-Switched Nd: YAG Laser is indicated for use with the beam-shrinking handpiece for the removal or significant reduction in intensity of black and/or blue-black tattoos. The laser, without the beam-shrinking handpiece is also indicated for use in combination with the ThermoLase supplied topical lotion in removing or lightening unwanted facial or body hair and for laser skin resurfacing.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The SoftLight Q-Switched Nd:YAG Laser Tattoo Removal System consists of the laser device and a beam-shrinking handpiece which is attached to the aperture of the laser. The handpiece focuses the beam from the laser. The absorption of energy from the beam by the dyes in the tattoo results in the formation and liberation of mechanical and heat energy sufficient to lighten the pigment of the tattoo.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical trials involving human subjects subjected to two laser treatments, four weeks apart and followed for an additional eight weeks showed no safety issues. The treatments were shown to reduce the intensity of tattoos in the treated areas.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
Laser Tattoo Removal
K 993209
ThermoLase Corporation 510(k) Premarket Notification
DEC 23 1999
510(k) Summary ThermoLase SoftLight™ Laser Tattoo Removal
| Submitter: | ThermoLase Corporation
10455 Pacific Center Court
San Diego, CA 92121-4339 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name: | SoftLight Q-Switched Nd:YAG Laser |
| Common Name: | Q-Switched Nd:YAG Laser |
| Classification Name: | Instrument, Surgical, Laser Powered (and accessories). |
| Legally marketed predicate: | ThermoLase SoftLight Q-Switched Nd:YAG Laser with optional
SofTouch™ Scanner accessory. The predicate device is a dermal
laser for use in combination with a ThermoLase supplied topical
lotion for removal or lightening of unwanted facial or body hair. It
is also indicated for use with the same lotion for laser skin
resurfacing. The operating wavelength is 1064nm and is typically
operated at a fluence of up to 3.0 J/cm². |
| Device description: | The SoftLight Q-Switched Nd:YAG Laser Tattoo Removal System
consists of the laser device and a beam-shrinking handpiece
which is attached to the aperture of the laser. |
| The handpiece focuses the beam from the laser. The absorption
of energy from the beam by the dyes in the tattoo results in the
formation and liberation of mechanical and heat energy sufficient
to lighten the pigment of the tattoo. | |
| Indications for Use: | The ThermoLase SoftLight Q-Switched Nd:YAG Laser is indicated
for use with the beam-shrinking handpiece for the removal or
significant reduction in intensity of black and/or blue-black tattoos.
The laser, without the beam-shrinking handpiece is also indicated
for use in combination with the ThermoLase supplied topical lotion
in removing or lightening unwanted facial or body hair and for
laser skin resurfacing. |
| Technological characteristics: | Laser
The ThermoLase SoftLight Q-Switched Nd:YAG Laser is designed
to deliver a nominal output of 1.0 Joule per pulse at a fixed
operating wavelength of 1064 nm in a collimated beam. The
pulse rate is 1, 2, 5 or 10 pulses per second (Hz) and single shot.
The Q-Switched output pulses are nominally 6-20 nsec in
duration. The output beam is delivered through a seven mirror
articulated arm and beam delivery handpiece which allows easy
access to the treatment site. The collimated laser beam gives a
fixed spot size of between 6 and 7 mm at the treatment site. This
laser can be set to deliver fluences of between approximately 1 to
3.5 J/cm². |
1
| The laser energy and repetition rate settings are adjusted and monitored through a microprocessor-controlled keypad on the control panel of the laser. These operating parameters are virtually identical to the operating parameters of the ThermoLase SoftLight Q-Switched Nd:YAG Laser System on which substantial equivalence is based. | |
|---|---|
| Beam-shrinking Handpiece The accessory beam-shrinking handpiece reduces the aperture to 5 mm. The 5mm spot size will convert the fluence of a 2.9 J/cm² setting to 5.68 J/cm². This is the setting used most frequently for the tattoo removal application. | |
| Performance data: | Clinical trials involving human subjects subjected to two laser treatments, four weeks apart and followed for an additional eight weeks showed no safety issues. The treatments were shown to reduce the intensity of tattoos in the treated areas. |
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 1999
Mr. Gerald Feldman. MPH. MBA President and Chief Executive Officer ThermoLase Corporation 6 Westminster Place Monmouth Junction, New Jersey 08852
K993209 Re: Trade Name: SoftLight O-Switched Nd: YAG Laser Regulatory Class: II Product Code: GEX Dated: September 17, 1999 Received: September 24, 1999
Dear Mr. Feldman:
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 (OS) 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. Gerald Feldman, MPH, MBA
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 vour 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,
Russell W. Ayres
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K993209
Device Name: ThermoLase SoftLight Q-Switched Nd:YAG Laser Tattoo Removal System
Indications for Use:
The ThermoLase SoftLight Q-Switched Nd: YAG Laser is indicated for use with the beam-shrinking handpiece for the removal or significant reduction in intensity of black and/or blue-black tattoos. The laser, without the beam-shrinking handpiece is also indicated for use in combination with the ThermoLase supplied topical lotion in removing or lightening unwanted facial or body hair and for laser skin resurfacing.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Russell Rogers for J20
(Division Sign-Off) Division of General Restor 5 .. AK) Number _
Prescription Use N (Per 21 CFR 801.109)
OR
Over-The Counter Use
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