(90 days)
Not Found
No
The summary describes a laser device for hair removal and does not mention any AI or ML components or functionalities.
No
The device is intended for hair removal, which is typically considered a cosmetic procedure rather than a therapeutic one addressing a disease or medical condition.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to effect hair removal", which is a treatment, not a diagnostic purpose.
No
The device description clearly states it is a laser device with hardware components like fiber optics and a handpiece, indicating it is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to effect hair removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles." This is a therapeutic/cosmetic procedure performed directly on the patient's body.
- Device Description: The device is a laser that delivers energy to the treatment site via fiber optics and a handpiece held in contact with the skin. This describes a device used externally on the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of any biological specimens.
The information provided clearly indicates this is a medical device used for a procedure performed directly on the patient, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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)
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
None required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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
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 Avenue |
| Lexington, MA 02173 | |
| Contact Person: | Mr. Steven Armstrong |
| Vice President of Quality Assurance | |
| and Service | |
| President, Palomar Medical | |
| Technologies, Inc. | |
| Telephone: | 781-676-7300 |
| 781-676-7330 (Fax) | |
| Preparation Date: | |
| (of the Summary) | January 30, 1998 |
| Device Trade Name: | LightSheer™ |
| Common Name: | Ruby Laser, long pulse |
| Classification | |
| Name | Laser surgical instrument; for use in general and plastic |
| surgery and in dermatology (see: 21 CFR 878.4810). | |
| Product Code: GEX | |
| Panel: 79 | |
| Legally marketed | |
| predicate devices | The LightSheer™ is substantially equivalent to the EpiLaserR. |
| Device Description: | 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. |
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 patients
with skin types 1 - 4 through selective targeting of melanin in
hair follicles.
The LightSheer™ is a prescription device (12 CFR 801.109) |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison: | The specifications, performance and intended use of the
LightSheer™ are the same or similar as the EpiLaserR described
in K963947. The differences between the lasers are not
significant in terms of the performance or intended use of the
LightSheer™ |
| Performance Data: | None required. |
| SUMMARY: | The similarities of the LightSheer™ and the EpiLaserR
demonstrate that the two lasers are substantially equivalent.
The differences between the LightSheer™ and EpiLaserR do not
pose 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 the
LightSheer™ and the EpiLaserR. |
| Additional:
Information | None requested |
| CONCLUSION: | The LightSheer™ long pulse ruby laser is substantially
equivalent 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