The ProLite™ Pulsed Light System, equipped with the HR handpiece and 600 nanometer filter, is intended for the removal of unwanted hair in all Fitzpatrick skin types.

The ProLite™ Pulsed Light System, equipped with the SR handpiece and 550 or 580 nanometer filters, is intended for the treatment of benign pigmented lesions and the removal of tattoos, the treatment of vascular lesions, and the treatment of shallow facial veins, telangiectasia, facial hemangiomas, and rosacea vascular lesions

The 550 nanometer filter may be more efficient for Types I and II skin. The 580 nanometer filter may be more efficient for Types III and IV skin.

Device Description

The ProLite™ Pulsed Light System uses a Xenon Flash Lamp which is filtered to specified wavelengths for its intended uses. The System consists of a cabinet with power supply, a distilled water cooling system, the microcontroller, an umbilical which attaches to a handpiece which houses the selected filter.

AI/ML Overview

The provided text explicitly states, "Performance Data: None required." It clarifies that "The claim of substantial equivalence is based the fact that the ProLite™ Pulsed Light System described in this premarket notification is the same as described in several previous premarket notifications. No changes in specifications, performance characteristics, or indications for use are proposed."

Therefore, based on the input text:

A table of acceptance criteria and the reported device performance: Not provided. The submission claims no performance data was required because the device is "substantially equivalent to itself."
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no performance data or test set was reported.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no ground truth was established for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication was performed.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a pulsed light system, not an AI-assisted diagnostic tool, and no comparative effectiveness study was reported.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical system, not an algorithm, and no standalone performance study was reported.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth was established or used for performance evaluation.
The sample size for the training set: Not applicable, as no training set was mentioned or used for device development or evaluation.
How the ground truth for the training set was established: Not applicable, as no training set or its ground truth was established.

Summary

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SECTION 10

510(k) SUMMARY

This 510(k) summary of safety and effectiveness for the ProLite™ Pulsed Light System is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant: Big Sky Laser Technologies, Inc.
601 Haggerty Lane, Suite C Address: Bozeman, MT 59715
Big Sky Laser Technologies, Inc Manufacturer:
Mr. Patrick Maine Contact Person: President/CEO
406-586-0131 Telephone: 406-586-2924 (Fax)

Preparation Date: April 2002 (of the Summary)

ProLite™ Pulsed Light System Device Name:

Common Name: Pulsed Flash Lamp
Classification: Instrument, Surgical powered laser (claimed predicate) Class II medical device: (21 CFR 878.4810) (Name)

Product Code: GEX Panel: 79

Predicate devices: The ProLite™ Pulsed Light System is substantially equivalent to itself.

Device description: The ProLite™ Pulsed Light System uses a Xenon Flash Lamp which is filtered to specified wavelengths for its intended uses. The System consists of a cabinet with power supply, a distilled water cooling system, the microcontroller, an umbilical which attaches to a handpiece which houses the selected filter.
The ProLite™ Pulsed Light System, equipped with the HR handpiece and 600 Indications: nanometer filter, is intended for the removal of unwanted hair in all Fitzpatrick skin types.

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The ProLite™ Pulsed Light System, equipped with the SR handpiece and 550 or 580 nanometer filter, is intended for the treatment of benign pigmented lesions and the removal of tattoos, the treatment of vascular lesions, and the treatment of shallow facial veins, telangiectasia, facial hemangiomas, and rosacea vascular lesions

The 550 nanometer filter may be more efficient for Types I and II skin. The 580 nanometer filter may be more efficient for Types III and IV skin.

The Center for Medical Devices and Radiological Health has concluded that the ProLite™ Pulsed Light System be labeled as a restricted device as follows:

"CAUTION: Federal (US) law restricts the use of this device to licensed professionals."

Performance Data: None required. The claim of substantial equivalence is based the fact that the ProLite™ Pulsed Light System described in this premarket notification is the same as described in several previous premarket notifications. No changes in specifications, performance characteristics, or indications for use are proposed.
CONCLUSION: Based on the information in the notification Big Sky Laser Technologies, Inc., believes that ProLite™ Pulsed Light System is substantially equivalent to itself, i.e., the claimed predicate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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DEPARTMENT OF HEALTH & S

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2002

Mr. Patrick Maine President and CEO Big Sky Laser Technologies, Inc. 601 Haggerty Lane, Suite C P.O. Box 8100 Bozeman, MT 59715

Re: K021304

Trade/Device Name: ProLite™ Pulsed Light System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: April 19, 2002

Received: April 24, 2002

Dear Mr. Maine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Patrick Maine

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Mark N Milkman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 7

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):	k. 021304
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Device Name: ProLite™ Pulsed Light System

Indications for Use Statement:

The ProLite™ Pulsed Light System, equipped with the HR handpiece and 600 nanometer filter, is intended for the removal of unwanted hair in all Fitzpatrick skin types.

The 550 nanometer filter may be more efficient for Types I and II skin. The 580 nanometer filter may be more efficient for Types III and IV skin.

The Center for Medical Devices and Radiological Health has concluded that the ProLite™ Pulsed Light System be labeled as a restricted device as follows:

"CAUTION: Federal (US) law restricts the use of this device to licensed professionals."

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Prescription Use V (Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Mark-McMillan

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K021304

Regulation Number and Section

§ 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.