(53 days)
The Epilaser® I
No
The summary describes a laser hair removal device with hardware upgrades (laser head, fiber optic components, hand pieces). There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is intended for hair removal, which is generally considered a cosmetic procedure rather than therapeutic. The "Intended Use" focuses on altering appearance through hair removal, not on treating a disease, injury, or other medical condition.
No
The device is used for hair removal, which is a therapeutic rather than a diagnostic purpose. It selectively targets melanin in hair follicles to effect hair removal, not to diagnose a condition.
No
The device description explicitly details hardware components like a laser head, fiber optic beam connector, fiber optic, and modified hand pieces.
Based on the provided information, 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 in dermatology and plastic surgery." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description details a laser system and its components used for delivering energy to the skin. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Using reagents or assays.
Therefore, the Epilaser I, as described, is a therapeutic device used for hair removal, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Epilaser I is intended to effect hair removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The upgrade kit for the Epilaser® I consists of a laser head with a slightly higher energy output, a fiber optic beam connector with a standard SMA 905 connector, a fiber optic, and modified hand pieces adapted with a quick connect to the fiber optic.
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.
The Epilaser® I
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.
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.
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MAR 1 0 1998
: *
K980160
APPENDIX E
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) SUMMARY
Epilaser® I Normal Mode Ruby Laser
This 510(k) summary of safety and effectiveness involves a post-sale upgrade of the Epilaser I and is submitted 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. Anthony Fiorillo |
| President, Palomar Medical | |
| Technologies, Inc. | |
| Telephone: | 617-676-7300 |
| 617-676-7330 (Fax) | |
| Preparation Date: | |
| (of the Summary) | December 1997 |
| Device Trade Name: | Upgrade for the Epilaser® I (an accessory to the Epilaser® I). |
| Common Name: | Ruby Laser |
| 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 Epilaser® I is the legally marketed device. Installation of |
| Description of | |
| the Device: | The upgrade kit for the Epilaser® I consists of a laser head with |
| a slightly higher energy output, a fiber optic beam connector | |
| with a standard SMA 905 connector, a fiber optic, and | |
| modified hand pieces adapted with a quick connect to the fiber | |
| optic. |
1
| Intended Use of the Device: | The intended use Epilaser R I is not affected by installation of the upgrade kit. |
|---|---|
| Comparison: | The operational specifications, performance and intended use of the Epilaser R I are not affected by the installation of the upgrade kit. The changes in specifications after installation of the upgrade kit, e.g., a fiber optic in place of an articulated arm, do not affect the performance characteristics of the Epilaser R I. |
| Performance Data: | None required. |
| SUMMARY: | Installation of the upgrade kit has no effect on the performance, instructions for use, or indications of use for the Epilaser R I. The EpilaserR I performance and characteristics are not affected by the installation of the upgrade kit. |
| CONCLUSION: | The Epilaser R I laser after installation of the kit is substantially equivalent to the Epilaser R I prior to installation of the kit. |
| Additional Information | None requested |
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:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three curved lines or strokes, which is the department's emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 1998
Mr. Anthony Fiorillo · President Palomar Medical Technologies, Incorporated 45 Hartwell Avenue Lexington, Massachusetts 02173
Re: K980160 Trade Name: Epilaser I Upgrade Kit Regulatory Class: II Product Code: GEX Dated: January 13, 1998 Received: January 16, 1998
Dear Mr. Fiorillo:
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. ਬੋ 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.
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Page 2 - Mr. Fiorillo
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,
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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980160
APPENDIX D
- NOTE: The following indications for use are quoted from the Indications for Use statement for the Epilaser as described in K963947 (the laser has been renamed the Epilasers I). The indications for use in this APPENDIX are provided for the record; the installation of : ・ the upgrade kit does not affect or alter these indications. The upgrade kit itself does not have indications for use.
510(k) Number: 长安
Epilaser I Normal Mode Ruby Laser Device Name:
Indications for Use:
The Epilaser I is intended to effect hair removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
The Epilaser I was limited to prescription use at the substantially equivalent decision. (March 5, 1997). મે જ
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| -- | -------------------------------------------------------- | -- |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter-Use |
|---|---|
| --------------------------------------- | ------------------------- |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K980160 |
|---|---|
| --------------- | --------- |
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