(33 days)
Light and dark ink tattoo removal and pigmented lesions removal
The Alex Ta2 Eraser is a flashlamp Q-switched solid state laser producing a broadband wavelength of 755 ±25nm.
The provided text is a 510(k) summary for the Alex Ta2 Eraser, a medical laser system. Upon review, it explicitly states "Nonclinical Performance Data: None provided at this time" and "Clinical Performance Data: None provided at this time."
Therefore, based on the provided document:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or reported device performance are provided as no clinical or nonclinical performance data was submitted. The device was deemed substantially equivalent to a predicate device without this data.
- Sample sized used for the test set and the data provenance: Not applicable, no test set was used as no performance data was provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no test set was used.
- Adjudication method for the test set: Not applicable, no test set was used.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, no studies were done. The device is a laser system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, no performance studies were done. The device is a laser system, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, no performance studies were done.
- The sample size for the training set: Not applicable, no performance studies were done. The device is a laser system, not an AI/ML algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable, no performance studies were done and no training set for an algorithm was needed.
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gpo131
510(k) Summary
FEB | 7 |998
| Submitter: | Light Age, Inc.2 Riverview DriveSomerset, New Jersey 08873 |
|---|---|
| Contact: | Rick FrostDir. of Sales |
| Date Summary Prepared: | January 13, 1998 |
| Device Trade Name: | Alex Ta2 Eraser |
| Common Name: | Medical laser system |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | Medlite/755 Alexandrite Laser System, Continuum Biomedical(K935631 and K961006). |
| Device Description: | The Alex Ta2 Eraser is a flashlamp Q-switched solid state laserproducing a broadband wavelength of 755 ±25nm. |
| Intended Use: | Light and dark ink tattoo removal and pigmented lesions removal |
| Comparison: | The Alex Ta2 Eraser is equivalent to the Medlite/755 Alexandrite LaserSystem (Continuum Biomedical) |
| Nonclinical Performance Data: | None provided at this time. |
| Clinical Performance Data: | None provided at this time. |
| Conclusion: | The Alex Ta2 Eraser is equivalent to the Medlite/755 Alexandrite LaserSystem (Continuum Biomedical) |
| Additional Information: | None requested at this time. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Rick Frost Director of Sales Light Age, Incorporated Two Riverview Drive Somerset. New Jersey 08873
FEB 1 7 1998
Re: K980131 Trade Name: Alex Ta2 Eraser Regulatory Class: II Product Code: GEX Dated: January 13, 1998 Received: January 15, 1998
Dear Mr. Frost:
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 world current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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
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Page 2 - Mr. Frost
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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.
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 of 1
K980/31
510(k) Number (if known):
Alex Ta2 Eraser
pending
Indications for Use:
.. .
Device Name:
Removal of dark and light ink tattoos and the removal of pigmented lesions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of ODRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K980131 |
| Prescription Use (Per 21 CFR 801.109) | X |
| OR | |
| Over-the-Counter Use | |
| (Optional Format 1-2-96) |
§ 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.