(90 days)
The LightSheer™ is intended to effect hair removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles. The LightSheer™ is a prescription device (12 CFR 801.109)
LightSheer™ laser is a long pulse ruby laser which delivers its energy to the treatment site via two quartz fiber optics. The beam exits from a chilled hand piece which is held in firm contact with the skin at the treatment site.
The provided text is a 510(k) summary for the LightSheer™ Long Pulse Ruby Laser. It outlines the device's intended use and claims substantial equivalence to a predicate device, the EpiLaser®. However, it explicitly states "None required" for performance data. This means a study specifically proving the device meets acceptance criteria was not conducted or reported in this submission because the FDA deemed it unnecessary due to the substantial equivalence claim.
Therefore, many of the requested details about acceptance criteria and a detailed study are not available in this document.
Here's what can be extracted based on the provided text, with clarifications where information is missing:
1. A table of acceptance criteria and the reported device performance
Since "Performance Data: None required" is explicitly stated, there are no specific numerical acceptance criteria or reported device performance metrics from a study to present in a table. The basis for clearance is substantial equivalence to the predicate device, not a new performance study.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| No specific acceptance criteria were defined or reported in this 510(k) summary. | No specific performance data was reported as "None required" due to substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable, as no performance data study was conducted or reported.
- Data Provenance: Not applicable.
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)
- Not applicable, as no performance data study was conducted or reported.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable, as no performance data study was conducted or reported.
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
- Not applicable. This device is a laser for hair removal, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a laser for hair removal, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable, as no performance data study was conducted or reported.
8. The sample size for the training set
- Not applicable, as no performance data study was conducted or reported.
9. How the ground truth for the training set was established
- Not applicable, as no performance data study was conducted or reported.
Summary of Device Acceptance:
The LightSheer™ Long Pulse Ruby Laser was accepted based on a substantial equivalence claim to the legally marketed predicate device, the EpiLaser®. The 510(k) summary argues that "The specifications, performance and intended use of the LightSheer™ are the same or similar as the EpiLaser®" and "The differences between the lasers are not significant in terms of the performance or intended use of the LightSheer™." Therefore, the FDA did not require a new performance study to prove the device meets specific acceptance criteria.
{0}------------------------------------------------
K 9804/20
APPENDIX F
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) SUMMARY
LightSheer™ Long Pulse Ruby Laser
This 510(k) summary of safety and effectiveness is provided in accordance with the requirements of SMDA 1990 following Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | Palomar Medical Technologies, Inc. |
|---|---|
| Address: | 45 Hartwell AvenueLexington, MA 02173 |
| Contact Person: | Mr. Steven ArmstrongVice President of Quality Assuranceand ServicePresident, Palomar MedicalTechnologies, Inc. |
| Telephone: | 781-676-7300781-676-7330 (Fax) |
| Preparation Date:(of the Summary) | January 30, 1998 |
| Device Trade Name: | LightSheer™ |
| Common Name: | Ruby Laser, long pulse |
| ClassificationName | Laser surgical instrument; for use in general and plasticsurgery and in dermatology (see: 21 CFR 878.4810).Product Code: GEXPanel: 79 |
| Legally marketedpredicate devices | The LightSheer™ is substantially equivalent to the EpiLaserR. |
| Device Description: | LightSheer™ laser is a long pulse ruby laser which delivers itsenergy to the treatment site via two quartz fiber optics. Thebeam exits from a chilled hand piece which is held in firmcontact with the skin at the treatment site. |
Image /page/0/Picture/9 description: The image shows a close-up of the numbers 3 and 5. The numbers are printed in a bold font and appear to be part of a larger sequence. Below the numbers 3 and 5 are some characters in another language.
11
MAY 4 1998
{1}------------------------------------------------
| Intended Use of | The LightSheer™ is intended to effect hair removal of patientswith skin types 1 - 4 through selective targeting of melanin inhair follicles.The LightSheer™ is a prescription device (12 CFR 801.109) |
|---|---|
| Comparison: | The specifications, performance and intended use of theLightSheer™ are the same or similar as the EpiLaserR describedin K963947. The differences between the lasers are notsignificant in terms of the performance or intended use of theLightSheer™ |
| Performance Data: | None required. |
| SUMMARY: | The similarities of the LightSheer™ and the EpiLaserRdemonstrate that the two lasers are substantially equivalent.The differences between the LightSheer™ and EpiLaserR do notpose any significant or deleterious effects on either the safety,performance, use, or effectiveness of the LightSheer™.The fluences to tissue at the treatment site are the same for theLightSheer™ and the EpiLaserR. |
| Additional:Information | None requested |
| CONCLUSION: | The LightSheer™ long pulse ruby laser is substantiallyequivalent to the EpiLaserR. |
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
.
,
arras
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.
4 1998 MAY
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steven Armstrong Vice President of Quality Assurance and Service Palomar Medical Technologies, Incorporated 45 Hartwell Avenue Lexington, Massachusetts 02173
Re: K980420 Trade Name: LightSheer™ Long Pulse Ruby Laser Requlatory Class: II Product Code: GEX Dated: February 2, 1998 February 3, 1998 Received:
Dear Mr. Armstrong:
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 Existing major be subject to such additional controls. regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬੈ 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.
{3}------------------------------------------------
Page 2 - Mr. Armstrong
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,
Acceffe
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
510(k) Number: K980420
LightSheer™ Long Pulse Ruby Laser Device Name:
Indications for Use:
The LightSheer™ is intended to effect hair removal of patients with skin types I - 4 through selective targeting of melanin in hair follicles.
Note: The EpiLaser" was limited to prescription use at the time of the substantially equivalent Note: The EpiLaser" was limited to prescription use at the mas of the Books of the LightSheer™ be a limited to prescription use also.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1985 - 1997
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Division Sign-Off)
Division of General Restorative Devices K980420
510(k) Number
010
§ 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.