(161 days)
The EpiLaser™ Normal Mode Ruby Laser is intended to effect a permanent reduction of hair in patients with skin types I-IV through selective targeting of melanin in hair follicles.
The LipiLaser® is intended to effect temporary hair reduction in skin types I-IV . The LipiLaser® 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.
The EpiLaser™ operates at a wavelength of 694.3 nanometers and the beam has a pulse duration of 0.2 to 3.0 milliseconds (msec). The laser energy is delivered to the treatment sites by an articulated arm. Energy fluences of 10-60 J/cm2 are achieved under conditions of intended use. A water-cooled handpiece (spot sizes of 7 or 10 mm) is held firmly against the treatment site.
This document describes the Palomar EpiLaser™ Normal Mode Ruby Laser, a device intended for permanent hair reduction.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state pre-defined acceptance criteria with numerical thresholds. Instead, it describes a clinical study that demonstrated the device's effectiveness. The core acceptance criterion, as implied by the FDA's "substantial equivalence" finding, would be that the device achieves "permanent reduction of hair." The FDA further clarifies this as "a long term, stable reduction in the number of hairs regrowing after a treatment regime," explicitly stating it "shall not permit a claim using the terms permanent elimination or permanent removal of all hair in the treated area after a treatment."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Permanent hair reduction | The study demonstrated that EpiLaser™ is a safe and effective tool for hair removal, resulting in a permanent reduction of hair. |
| Safety (no adverse events) | There was no scarring or depigmentation of the skin in any subject. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document only states "Observations of hair and skin responses were recorded prior to treatment and at 1, 3, 6, 9, 12 and 24 months after treatment." It does not specify the number of subjects included in the clinical study.
- Data Provenance: The data appears to be prospective as observations were recorded at various time points after treatment. The country of origin of the data is not specified but is presumably the United States, given the FDA submission context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not provide details on how the assessment of "permanent reduction of hair" was independently verified or by whom. It states "Observations of hair and skin responses were recorded," which could imply clinical observation by study investigators. No information about external experts or their qualifications is provided.
4. Adjudication Method for the Test Set:
No adjudication method is described.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No MRMC study was performed or mentioned. This is a medical device for hair removal, not an AI diagnostic tool, so an MRMC study would generally not be applicable.
6. Standalone Performance Study:
This device is a hardware laser system; therefore, the concept of a "standalone algorithm only" performance study is not applicable. The device's performance inherently involves the direct application of the laser by a user.
7. Type of Ground Truth Used:
The ground truth used was clinical observation and assessment of hair regrowth over a 24-month period. The FDA defines "permanent hair reduction" based on this observable outcome.
8. Sample Size for the Training Set:
This document describes a clinical study for a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI. The study described is an efficacy and safety evaluation.
9. How the Ground Truth for the Training Set was Established:
As there is no AI training set, this question is not applicable. The "ground truth" for the device's performance was established through clinical follow-up as described in point 7.
{0}------------------------------------------------
Jul 21 1998
Attachment 6
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EpiLaser™ Normal Mode Ruby I has sions builted 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 |
|---|---|
| Address: | 45 Hartwell AvenueLexington, MA 02 |
| Contact Person: | Tony Fiorillo |
| Telephone: | 781-676-7300 |
| Preparation Date: | February 3, 1998 |
| Device Trade Name: | EpiLaser™ Normal Mode Ruby Laser |
| Common Name: | Ruby Laser |
| Classification Name: | Laser surgical instrument for use in General andPlastic Surgery and in Dermatology(see: 21 CFR 878-4810).Product Code: GEXPanel: 79 |
| Legally-Marketed Predicate Device: | EpiLaser™ Normal Mode Ruby LaserPalomar Medical ProductsK963947 |
| System Description: | The EpiLaser™ operates at a wavelength of 694.3nanometers and the beam has a pulse duration of 0.2to 3.0 milliseconds (msec). The laser energy isdelivered to the treatment sites by an articulatedarm. Energy fluences of 10-60 J/cm2 are achievedunder conditions of intended use. A water-cooledhandpiece (spot sizes of 7 or 10 mm) is held firmlyagainst the treatment site. |
{1}------------------------------------------------
Intended Use of the Device:
The EpiLaser™ Normal Mode Ruby Laser is intended to effect a permanent reduction of hair in patients with skin types I-IV through selective targeting of melanin in hair follicles.
There are no technological differences.
Performance Data:
Results of Clinical Study:
ﻪ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
Observations of hair and skin responses were recorded prior to treatment and at 1, 3, 6, 9, 12 and 24 months after treatment. There was no scarring or depigmentation of the skin in any subject. The study demonstrated that EpiLaser™ is a safe and effective tool for hair removal, resulting in a permanent reduction of hair.
Conclusion:
Based on the foregoing, the EpiLaser™ is effective for producing a permanent reduction of hair.
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which consists of a stylized human figure with three heads, representing the department's focus on health, well-being, and human services. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is simple and recognizable, conveying the department's mission and purpose.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 21 1998
Ms. Marcy Moore Manager of Clinical Studies Palomar Medical Products, Inc. 9516 Candor Oaks Drive Raleigh, North Carolina 27615
Re : K980517 Trade Name: EpiLaser™ Normal Mode Ruby Laser Regulatory Class: II Product Code: GEX Dated: June 12, 1998 Received: June 15, 1998
Dear Ms. Moore:
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 legally marketed predicate 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). Permanent hair reduction, in the context of this indication for use, shall mean a long term, stable reduction in the number of hairs regrowing after a treatment regime. It shall not permit a claim using the terms permanent elimination or permanent removal of all hair in the treated area after a You may, therefore, market the device, subject to treatment. 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 Requlations, Title 21, Parts 800 to 895. ਕ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice reguirements, 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
{3}------------------------------------------------
Page 2 - Ms. Marcy Moore
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 requlations.
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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
la M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
The LipiLaser® is intended to effect temporary hair reduction in skin types I-IV . The LipiLaser® 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.
Prescription Use
(Per 21 CFR 801.109)
pcseel
oral Restore
§ 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.