(90 days)
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.
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.
The provided text describes the 510(k) premarket notification for the ThermoLase SoftLight™ Laser Tattoo Removal system, which received clearance in 1999. The information primarily focuses on the device's technical specifications and intended use, with limited details on the study design for its performance data beyond a brief mention of "clinical trials." The acceptance criteria are not explicitly stated as quantitative metrics.
Here's an attempt to extract and organize the requested information based on the provided text:
Acceptance Criteria and Device Performance for Laser Tattoo Removal
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety Assessment: No safety issues after multiple treatments. | "Clinical trials... showed no safety issues." |
| Effectiveness: Reduce intensity of black and/or blue-black tattoos. | "The treatments were shown to reduce the intensity of tattoos in the treated areas." |
Note: The acceptance criteria are inferred from the safety and efficacy statements in the "Performance data" section. Specific quantitative thresholds (e.g., a percentage reduction in tattoo intensity) are not provided in the document.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document only mentions "Clinical trials involving human subjects."
- Data Provenance: The trials involved "human subjects" but the country of origin is not specified. The text doesn't indicate if the study was retrospective or prospective, but clinical trials involving treatments and follow-up are typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC study was not described. The document focuses on the device's direct effect on tattoos, not on comparing human readers' performance with and without AI assistance (as AI assistance is not part of this device).
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable as this is not an AI-assisted device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes, in the sense that the device's performance was evaluated for its direct effect on tattoos. The "Performance data" section describes the device's standalone action of reducing tattoo intensity on human subjects, without mention of a human-in-the-loop component for this specific indication.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for effectiveness appears to be a subjective assessment of "reduction in intensity" of tattoos. It's likely based on visual assessment by clinicians or potentially patient-reported outcomes, but the specific method (e.g., standardized photography, scoring scales) is not detailed. It is mentioned that "no safety issues" were observed, implying clinical observation as the ground truth for safety.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not provided. This device is a laser system, not an AI model requiring a training set in the conventional sense. The "training" would refer to engineering and design iterations rather than data training.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. This question is relevant for AI/machine learning models, not for a laser device. The "ground truth" during device development would be related to engineering specifications and preclinical testing, which are not outlined here.
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Laser Tattoo Removal
K 993209
ThermoLase Corporation 510(k) Premarket Notification
DEC 23 1999
510(k) Summary ThermoLase SoftLight™ Laser Tattoo Removal
| Submitter: | ThermoLase Corporation10455 Pacific Center CourtSan 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 optionalSofTouch™ Scanner accessory. The predicate device is a dermallaser for use in combination with a ThermoLase supplied topicallotion for removal or lightening of unwanted facial or body hair. Itis also indicated for use with the same lotion for laser skinresurfacing. The operating wavelength is 1064nm and is typicallyoperated at a fluence of up to 3.0 J/cm². |
| Device description: | The SoftLight Q-Switched Nd:YAG Laser Tattoo Removal Systemconsists of the laser device and a beam-shrinking handpiecewhich is attached to the aperture of the laser. |
| The handpiece focuses the beam from the laser. The absorptionof energy from the beam by the dyes in the tattoo results in theformation and liberation of mechanical and heat energy sufficientto lighten the pigment of the tattoo. | |
| Indications for Use: | The ThermoLase SoftLight Q-Switched Nd:YAG Laser is indicatedfor use with the beam-shrinking handpiece for the removal orsignificant reduction in intensity of black and/or blue-black tattoos.The laser, without the beam-shrinking handpiece is also indicatedfor use in combination with the ThermoLase supplied topical lotionin removing or lightening unwanted facial or body hair and forlaser skin resurfacing. |
| Technological characteristics: | LaserThe ThermoLase SoftLight Q-Switched Nd:YAG Laser is designedto deliver a nominal output of 1.0 Joule per pulse at a fixedoperating wavelength of 1064 nm in a collimated beam. Thepulse rate is 1, 2, 5 or 10 pulses per second (Hz) and single shot.The Q-Switched output pulses are nominally 6-20 nsec induration. The output beam is delivered through a seven mirrorarticulated arm and beam delivery handpiece which allows easyaccess to the treatment site. The collimated laser beam gives afixed spot size of between 6 and 7 mm at the treatment site. Thislaser can be set to deliver fluences of between approximately 1 to3.5 J/cm². |
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| 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. |
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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
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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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§ 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.