(167 days)
The LaseAway Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The LaseAway Alexandrite Laser System is intended for use only by qualified physicians trained in the safe operation of the system.
The LaseAway 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 LaseAway 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.
The provided document is a 510(k) premarket notification for the "LaseAway Alexandrite Laser System," a device intended for cosmetic hair removal. It details the device's description, indications for use, safety features, and a comparison to predicate devices, ultimately claiming substantial equivalence.
However, this document does not contain information on specific acceptance criteria and a study proving the device meets those criteria, as typically found in clinical trial reports or performance validation studies. The 510(k) summary focuses on demonstrating substantial equivalence to already marketed devices, primarily through descriptive comparison of technical specifications and safety standards, rather than presenting a performance study against predefined acceptance metrics.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided: The document does not specify quantitative acceptance criteria for device performance (e.g., a certain percentage of hair reduction after a set number of treatments) nor does it present a study with reported performance data against such criteria. The "Conclusion" section states the device is "safe and effective," but this is a general statement from the manufacturer's summary, not a report of specific performance metrics from a study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided: No test set or clinical study data is reported in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided: No test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided: No test set or adjudication method is described.
5. 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
- Cannot be provided: This device is a laser system for hair removal, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided: As this is a physical laser device, the concept of "standalone algorithm performance" does not apply in the context of AI or software. Its performance relies on human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided: Since no specific performance study is detailed, no ground truth methodology is described.
8. The sample size for the training set
- Cannot be provided: No training set is mentioned as part of a performance study.
9. How the ground truth for the training set was established
- Cannot be provided: No ground truth for a training set is mentioned.
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K9823/6
Image /page/0/Picture/1 description: The image shows the logo for Silver Creek Surgical. The logo is in black and white and features the words "Silver Creek" in a stylized font, with the word "Surgical" underneath in a smaller font. To the right of the logo is a starburst design. Above the logo, the date "DEC 16 1998" is printed in a simple font.
1310 Rockbridge Road • Suite E • Stone Mountain, GA 30087 770-931-1090 • Fax 770-931-9930 E-Mail: Info@silvercreeksurgical.com Website: http://www.silvercreeksurgical.com
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Date: | July 1, 1998 |
|---|---|
| Prepared By: | Lorna K. Linville |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48, Class II |
| Proprietary Name: | LaseAway Alexandrite Laser System |
| Indications: | The LaseAway Alexandrite Laser is intended for the cosmeticremoval of unwanted hair on adults (18 years or older). TheLaseAway Alexandrite Laser System is intended for use only byqualified physicians trained in the safe operation of the system. |
| Description: | The LaseAway Alexandrite Laser System is a medical devicewhich is capable of emitting an invisible treatment laser beam at awavelength of 755 nm under the guidance of a visible aimingbeam. In addition to the standard pulse width of nominally 1 Msecat 1Hz, the LaseAway Alexandrite Laser System will operate upto 3 Hz. Additionally, a single pulse is modulated to provide 6 x 1Msec pulses at 1.3 Hz. |
| Safety Features: | The safety features of the device have been designed inaccordance with relevant standards such as BS EN 60825-1(Safety of Laser Product) and BS EN 6061-2-22 (MedicalElectrical Equipment Safety). The labeling complies with 21 CFRsubchapter J for a Class IV laser product. |
| Predicate Devices: | The LaseAway Alexandrite Laser System is substantiallyequivalent to numerous devices that are currently commerciallyavailable. These devices include the Sharplan EpitouchAlexandrite Laser System (K973354 and K971874), Medlite/755Alexandrite Laser System (K961006), and Candella Q-SwitchedAlexandrite Lasers (K955662, K940173 and K944090). |
| Conclusion: | The LaseAway Alexandrite Laser System is safe and effectivefor the intended purpose of removal of unwanted body hair onadults 18 years of age or older. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design of an eagle or bird-like figure with three stylized lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 1998
Ms. Lorna K. Linville Quality/Regulatory Specialist Silver Creek Surgical 1310 Rockbridge Road, Suite E Stone Mountain, Georgia 30087
Re: K982316
Trade Name: LaseAway Alexandrite Laser System Regulatory Class: II Product Code: GEX Dated: October 1, 1998 Received: October 5, 1998
Dear Ms. Linville:
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 Ouality 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 - Ms. Lorna K. Linville
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,
fr
pollpa
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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510(k) Number (if Known): _K982 316
LaseAway Alexandrite Laser System Device Name:
Indications For Use:
The LaseAway Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The LaseAway 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 ODRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | 4982316 |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- |
OR
Over-The-Counter Use (Per 21 CFR 801.109)
(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.