(84 days)
K#942343, K#963947, K#962996
Not Found
No
The device description and summary of performance studies do not mention any AI or ML components. The control unit is described as analog, and the system relies on a footswitch and visible laser for operation.
Yes
The device is intended to remove tattoos and pigmented lesions, and to effect hair removal, which are therapeutic interventions.
No
The device description and intended use indicate that the LaseAway laser system is used for therapeutic purposes (tattoo removal, lesion treatment, hair removal), not for diagnosing conditions.
No
The device description clearly outlines hardware components such as a laser system, delivery arm, optics, control unit, energy detector, and footswitch. It is a physical laser system, 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 clearly states the device is for removing tattoos and pigmented lesions, and for hair removal. These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description details a laser system that delivers energy to the patient's skin. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens such as blood, urine, tissue, etc., to provide information about a person's health. This device does not perform such analysis.
Therefore, the LaseAway Long Pulse and Q-Switched Ruby Laser System is a therapeutic device used for dermatological and plastic surgery procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LaseAway Long Pulse and Q-Switched Ruby Laser System is intended to remove blue/black tattoos and benign dermal and epidermal piqmented lesions, and, 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
Using a wavelength of 694 nm., the LaseAway Long Pulse and Q-Switched Ruby Laser System consists of a Long Pulse and Q-Switched ruby laser together with an articulated delivery arm and focusing optics. The laser parameters are managed by an analog control unit which is coupled to the main system and calibration is facilitated by an energy detector in the front panel. The pulse operation is initiated by a footswitch and a visible helium neon laser to provide guidance for accurate beam delivery.
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
dermatology and plastic surgery.
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)
A clinical study was conducted using the device to support the claim for the treatment of hirsutism. A description of the protocol, including patient population, the results of the study and a summary of the data and analysis of the data to demonstrate the equivalence of the LaseAway Long Pulse and Q-Switched Ruby Laser System to legally marketed devices was supplied to the FDA. The aforementioned clinical data was obtained under IRB with written consent from patients. Included is a statement from the IRB that our protocol contents were considered under a non-significant risk device. The clinical data was obtained in accordance with 21 CFR Parts 50 and 56.
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.
K#942343, K#963947, K#962996
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
JUN 2 4 1997
EXHIBIT 1 Page 1 of 4
510 (K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
971193 The assigned 510 (k) number is:
1. Submitter's Identification:
Polytec PI, Inc. 23 Midstate Drive, Suite 104 Auburn, MA 01501
Contact Person: Mr. Mark Boardman Manager - Medical Laser Products
Date Summary Prepared: March 28, 1997
2. Name of the Device:
LaseAway Long Pulse and Q-Switched Ruby Laser System
3. Predicate Device Information:
-
- LaseAway Q-Switched Ruby Laser System, K#942343, Polytec PI, Inc.
- Epilaser™ Normal Mode Ruby Laser, K#963947, Spectrum 2. Medical Technologies
- EpiTouch™ Ruby Laser System, K#962996, Sharplan 3.
4 . Device Description:
Using a wavelength of 694 nm., the LaseAway Long Pulse and Q-Switched Ruby Laser System consists of a Long Pulse and Q-Switched ruby laser together with an articulated delivery arm and focusing optics. The laser parameters are managed by an analog control unit which is coupled to the main system and calibration is facilitated by an energy detector in the front panel. The pulse operation is initiated by a footswitch and a visible helium neon laser to provide guidance for accurate beam delivery.
1
EXHIBIT 1 Page 2 of 4
5. Intended Use:
The LaseAway Long Pulse and Q-Switched Ruby Laser System is intended to remove blue/black tattoos and benign dermal and epidermal piqmented lesions, and, to effect hair removal of patients with skin types 1:4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
6. Comparison to Predicate Devices:
The LaseAway Long Pulse and Q-Switched Ruby Laser System is substantially equivalent in design and function to other ruby laser systems on the market, specifically:
-
- The Polytec PI, Inc. LaseAway Q-Switched Ruby Laser System, K#942343;
-
- The Spectrum Medical Technologies EpiLaser™ Normal Mode Ruby Laser, K#963947; and
- The Sharplan EpiTouch™ Ruby Laser System, K#962446. 3.
The LaseAway Long Pulse and Q-Switched Ruby Laser System device is a Long Pulse and Q-Switched Ruby Laser and both the EpiLaser™ and EpiTouch devices are Non-Q-Switched (Long Pulse Exhibit #2 outlines all parameter differences; the Ruby) . intended use of the Sharplan Ruby Laser System is limited to use in dermatology for the removal of unwanted dark body hair.
A comparative description of the EpiTouch™ and EpiLaser™ devices to the LaseAway Long Pulse and Q-Switched Ruby Laser System is outlined below:
- . The EpiLaser™ (Spectrum Medical Technologies):
The Epilaser™ is a non-Q-Switched, long pulse, flashlamp pumped ruby laser with a wavelength of 694 nanometers. EpiLaser has an energy output of 25 joules allowing it to have a maximum fluences at 9 mm of 40 joules/cm² with a repetition rate of 0.5 Hz. The EpiLaser™ has a peak power output of 8.3 kilowatts with a pulse duration of 3 milliseconds. The laser beam is delivered to the treatment site through an articulated arm and a focusing handpiece where patient contact is made
2
EXHIBIT 1 Page 3 of 4
with a water cooled sapphire tip. The power supply needed for the system is 220 volts AC plus or minus 7 percent with a 30 amp current draw and an alternating current cycle 50 or 60 hertz. The exterior dimensions of the system are 40 inches tall by 24 inches wide by 44 inches deep and an operation weight of 790 pounds.
The major differences between the EpiLaser™ and LaseAway are the pulse width which is longer in the EpiLaser™ by almost 2 milliseconds, the energy delivery spot size which is almost double in the EpiLaser and the peak power which is higher in the Epilaser by almost 3 kilowatts. The minor differences are cooling handpiece, the exterior dimensions, in the the operating weight and the current draw needed to run the systems.
- . The EpiTouch™ (Sharplan):
The EpiTouch™ is a Q-Switched, long pulse, flashlamp pumped ruby laser with a wavelength of 694 nanometers. EpiTouch has an energy output of 5 joules allowing it to have a maximum fluences at 4 mm of 40 joules/cm² with a repetition rate of The EpiLaser™ has a peak power output of 1.2 Hz. 5.5 kilowatts with a pulse duration of 0.9 milliseconds. The laser beam is delivered to the treatment site through an articulated arm and a focusing handpiece where patient contact is made with an anodized aluminum. The power supply needed for the system is 220 volts AC plus or minus 10 percent with a 10 amp current draw and an alternating current cycle 50 or 60 hertz. The exterior dimensions of the system are 45 inches tall by 29 inches wide by 33 inches deep and an operating weight of 440 pounds.
The only difference between the EpiTouch™ and the LaseAway Long Pulse and Q-Switched Ruby Laser System is the exterior The LaseAway Long Pulse and Q-Switched Ruby Laser size. System is 24 inches tall by 47 inches wide by 21 inches deep.
7 . Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the LaseAway Long Pulse and Q-Switched Ruby Laser System, in
3
EXHIBIT 1 Page 4 of 4
the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" DCRND, which outlined Electrical, Mechanical and Environmental Performance Requirements.
Testing was conducted on the LaseAway Long Pulse and 0-Switched Ruby Laser System device per IEC-601-1 (electrical isolation) and IEC 601-1-2 (EMC testing).
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards.
8 . Discussion of Clinical Tests Performed:
A clinical study was conducted using the device to support the claim for the treatment of hirsutism. A description of the protocol, including patient population, the results of the study and a summary of the data and analysis of the data to demonstrate the equivalence of the LaseAway Long Pulse and Q-Switched Ruby Laser System to legally marketed devices was supplied to the FDA. The aforementioned clinical data was obtained under IRB with written consent from patients. Included is a statement from the IRB that our protocol contents were considered under a non-significant risk device. The clinical data was obtained in accordance with 21 CFR Parts 50 and 56.
9 . Conclusions:
The LaseAway Long Pulse and Q-Switched Ruby Laser System has the same intended use as the Spectrum Medical Technologies EpiLaser™ device and is similar in design and technology as this device as well as the Sharplan EpiTouch™ device: As our "Comparison to Predicate Devices" Section 6 outlines, as well as our clinical data, the LaseAway Long Pulse and Q-Switched Laser System raises no new questions of safety Ruby or effectiveness. Thus, when compared to the predicate devices, the LaseAway Long Pulse and Q-Switched Ruby Laser System did not incorporate any significant changes in intended use, method of operations, material or design that could affect safety or effectiveness.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan D. Goldstein-Falk Official Correspondent Polytec PI, Inc. . . . . . -23 Midstate Drive, Suite 212 Auburn, Massachusetts 01501
.UN 2 4 1997
Re: K971193
Trade Name: LaseAway Long Pulse and O-Switched Ruby Laser System Regulatory Class: II Product Code: GEX Dated: March 28, 1997 Received: April 1, 1997
Dear Ms. Goldstein-Falk:
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 commiance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
5
Page 2 - Ms. Susan D. Goldstein-Falk
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
6
EXHIBIT #B
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Page 1 of 1
Device Name: LaseAway Long Pulse and Q-Switched Ruby Laser System
Indications For Usc:
The LaseAway Long Pulse and Q-Switched Ruby Laser System is
intended to remove blue/black tattoos-and basiness on the intended to remove blue/black tattoos-and benign dermil and epitermal pigmented lesions, and, "to effect land and of melanin in hair follicles in dermany select be targeting of melanin in hair follicles in dermatology and plastic surgery.
(PLEASE DO NOT WRITE BELOW THESS LINE - CONTINUE ON ANOTHER PAGE IF MEEDED)
Concernence of CDRH, Office of Device Evaluation (ODE)
Elin Wilk
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971193
Prescription Use_ (/ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Cptical Formal 1-2-96)