(190 days)
Not Found
No
The description focuses on laser technology parameters (wavelength, pulse duration, energy fluence) and cooling mechanisms. There is no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is intended for hair reduction, not for diagnosing, treating, curing, or preventing disease, which are typical functions of a therapeutic device.
No
The device is described as operating at a specific wavelength and pulse duration to effect temporary or permanent hair reduction, which is a treatment/therapy, not a diagnostic purpose.
No
The device description explicitly details hardware components like a laser operating at a specific wavelength, pulse duration, energy fluences, and a thermoelectrically cooled handpiece, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary hair reduction" and "stable long-term, or permanent, hair reduction." This is a therapeutic or cosmetic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laser operating at a specific wavelength and pulse duration, applied directly to the skin. This is a physical intervention, not a test performed on a biological sample.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The LightSheer™ is a medical device used for a procedure performed on the patient's body, not a test performed on a sample taken from the body.
N/A
Intended Use / Indications for Use
The LightSheer™ is intended to effect temporary hair reduction in skin types I-IV. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction in skin types I-IV through selective targeting of melanim in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The LightSheer™ operates at a wavelength of 694.3 nanometers and the beam has a pulse duration of 3 and 20 milliseconds. Energy fluences of 10-60 J/cm² are achieved under conditions of intended use. A thermoelectrically cooled handpiece is held firmly against 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
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
None required.
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)
There are no technological differences. Clinical Data: None required. Conclusion: Based on the foregoing, the LightSheer™ is effective for producing a stable long-term, permanent reduction of hair.
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
8/4/99
Kg82980
Attachment 2
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness for the LightSheer™ Long Pulse Ruby Laser is submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) summary.
| Applicant: | Palomar Medical Products
Anthony Fiorillo, President | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Address: | 45 Hartwell Avenue
Lexington, MA 02
781-676-7300 | |
| Contact Person: | Marcy Moore
Manager of Clinical Studies | |
| Telephone: | 919-676-7166 | |
| Fax: | 919-676-3683 | |
| Preparation Date: | August 24, 1998 | |
| Device Trade Name: | LightSheer™ Long Pulse Ruby Laser | |
| 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 Device: | LightSheer™ Long Pulse Ruby Laser
Palomar Medical Products
K980420
EpiLaser® Normal Mode Ruby Laser
Palomar Medical Products
K980517 | |
| System Description: | The LightSheer™ operates at a wavelength of 694.3
nanometers and the beam has a pulse duration of 3
and 20 milliseconds. Energy fluences of 10-60 J/cm² | |
1
are achieved under conditions of intended use. A
thermoelectrically cooled handpiece is held firmly
against the treatment site.
| Intended Use of the Device: | The LightSheer™ is intended to effect temporary
hair reduction in skin types I-IV. The LightSheer™
is also intended to effect stable long-term, or
permanent, hair reduction in skin types I-IV through
selective targeting of melanin in hair follicles.
Permanent hair reduction is defined as a long-term
stable reduction in the number of hairs regrowing
after a treatment regime. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | There are no technological differences. |
| Clinical Data: | None required. |
| Conclusion: | Based on the foregoing, the LightSheer™ is effective
for producing a stable long-term, permanent
reduction of hair. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three wing-like extensions.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 1999
Ms. Marcy Moore Manager of Clinical Studies Palomar Medical Products, Inc. 9516 Candor Oaks Drive Raleigh, North Carolina 27615
K982980 Trade Name: LightSheer™ Long Pulse Ruby Laser Regulatory Class: II Product Code: GEX Dated: January 11, 1999 Received: January 12, 1999
Dear Ms. Moore:
Re:
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 (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 -- Ms. Marcy Moore
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,
Stipt Rivelo
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
4
INDICATION FOR USE STATEMENT
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: LightSheer ™ Long Pulse Ruby Laser
Indications for Use:
The LightSheer™ is intended to effect temporary hair reduction in skin types I-IV. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction in skin types I-IV through selective targeting of melanim in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| ------------------ | --------------------------------------------------- |
OR Over-the-Counter Use
(per 21 CFR,801,109)
Stpt. K982980
(Division-Off)
Division of General Restorative Devices
513(k) Number