The AIP Intense Pulsed Light System is an intense pulsed light device intended for the following: the treatment of benign vascular and pigmented lesions, and permanent hair reduction.

The AIP Intense Pulsed Light System is intended for use on all skin types (Fitzpatrick skin types I-VI).

Device Description

The AesThera AIP Intense Pulsed Light System is a 400—1200 nm intense pulsed light delivery system, powered by Photo-Pneumatic™ technology. It is a portable tabletop system with a hand piece connected by an umbilical to the main console. The hand piece incorporates an intelligent tip that is replaced with every patient treatment. A "sealed" intelligent tip is used to transmit light to the patient's skin. Light is emitted only through the tip and is always sealed with the patient's surrounding tissue during intense pulsed light emission. All emitted light is contained within the tip during treatment. The hand niece of the AIP Intense Pulsed Light System is uniquely designed to promote increased ergonomics with all user interface and controls located on the hand piece.

AI/ML Overview

This 510(k) summary does not contain the information requested for acceptance criteria and a study proving the device meets those criteria.

This document is a regulatory submission for a new medical device (AesThera AIP™ Intense Pulsed Light System) seeking 510(k) clearance by claiming substantial equivalence to existing predicate devices.

Here's why the requested information is not present:

Acceptance Criteria & Device Performance Table: This type of table, with specific performance metrics and acceptance thresholds, is typically found in a detailed clinical study report or a design verification and validation (V&V) report. The 510(k) summary focuses more on demonstrating equivalence to predicates in terms of intended use, technology, and safety features.
Study Details (Sample Size, Data Provenance, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set): The document provided is the 510(k) summary itself, which is a high-level overview. While the approval letter mentions the device is "substantially equivalent...for the indications for use stated in the enclosure," it does not detail any specific clinical studies performed by the manufacturer of this new device to establish its performance against predefined acceptance criteria.

Key points from the provided document relevant to its clearance:

Intended Use: Treatment of benign vascular and pigmented lesions, and permanent hair reduction on all skin types (Fitzpatrick I-VI).
Mechanism: Intense Pulsed Light (IPL) system (400-1200 nm) with proprietary Photo-Pneumatic™ technology.
Regulatory Approach: Substantial Equivalence to listed predicate devices (SkinStation™, StarLux™, MediLux™, EsteLux™, etc.). This means the manufacturer is asserting their device is as safe and effective as existing legally marketed devices, rather than submitting results from a de novo clinical trial with specific performance endpoints.
No detailed performance data: The document does not describe the specific performance metrics (e.g., clearance rates, adverse event rates, scar formation rates for lesion treatment; hair reduction percentage for hair removal) that would typically be evaluated in a study with acceptance criteria.

To answer your request, if this were a document describing a clinical study (which it is not), I would be looking for:

A specific section detailing clinical study results.
Explicitly stated primary and secondary endpoints.
Statistical analyses establishing the device's performance against pre-defined thresholds.

Since this is a 510(k) summary, the "acceptance criteria" are effectively that the device is substantially equivalent to established predicate devices, and the "study" is the comparison made to those predicates, along with a declaration of its intended use and technological characteristics. No specific performance study with a defined test set, ground truth, or expert consensus is described within this document for the new device.

Summary

{0}------------------------------------------------

510(k) Summary of Safety and Effectiveness

K041554

This 510(k) Summary of Safety and Effectiveness for the AesThera AIP ™ Intense Pulsed Light System is submitted in accordance with the requirements of the 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:	AesThera Corporation6111 Southfront RoadSuite ELivermore, CA 94550Bob AndersonChief Financial Officer
Contact Person:	C. Robert Payne, Jr., P.E.Regulatory Affairs ConsultantCRP EnterprisesP.O. Box 2608Morgan Hill, CA 95038Telephone: (408) 782-3024Fax: (408) 779-5284e-mail: myrvhome@ix.netcom.com
Preparation Date:	6 June 2004
Device Trade Name:	AIPTM Intense Pulsed Light System
Common Name:	Pulsed Flash Lamp
Classification Name:	Surgical instrument for use in general andplastic surgery and in dermatology(21 CFR 878-4810)
Product Code:	GEX
Predicate Devices:

SkinStation™, SPR™, ClearTouch™ , SpaTouch Pro (XtremeClear ™), . SpaTouch ™ (Radiancy (Israel) Ltd.) (K032205, K033181, K030897, K020856, K992482)
StarLux™, MediLux™, EsteLux™ (Palomar Medical Technologies, Inc.) . (K033549, K020941, K020453, K010618, K003886)

{1}------------------------------------------------

Device Description:

Intended Use of the Device:

The AIP Intense Pulsed Light System is an intense pulsed light device intended for the following: the treatment of benign vascular and pigmented lesions, and permanent hair reduction.

The AIP Intense Pulsed Light System is intended for use on all skin types (Fitzpatrick skin types I-VI).

Substantial Equivalence to Predicate Devices:

The AIP Intense Pulsed Light System, which is intended for the following; the treatment of benign vascular and pigmented lesions, and permanent hair reduction, is substantially equivalent in design and materials to the listed predicate devices.

{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. Inside the circle is an abstract symbol of an eagle, with three stylized lines representing the bird's wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2005

AesThera Corporation C/o C. Robert Payne, Jr., P.E. RA/ QA Consultant CRP Enterprises P.O. Box 2608 Morgan Hill, California 95038

Re: K041554 Trade/Device Name: AIP™ Intense Pulsed Light System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 16, 2005 Received: March 21, 2005

Dear Mr. Payne:

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.

{3}------------------------------------------------

Page 2 - Mr. C. Robert Payne, Jr., P.E.

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), please contact the Office of Compliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Ron G. Th

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

510(k) Number:	New submissionNAME OF LOT LIES LOOM	1 00	Caroline, and and and the production of	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

AIP TM Intense Pulsed Light System Device Name:

Indications for Use:

The AIP Intense Pulsed Light System is an intense pulsed light device intended for the following: the treatment of benign vascular and pigmented lesions, and permanent hair reduction.

The AIP Intense Pulsed Light System is intended for use on all skin types (Fitzpatrick skin types I-VI).

Prescription Use X

OR (per 21 CFR 878-4810)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Please do not write below this line - Continue on another page if needed)

	Concurrence of CDRH, Office of Device Evaluation (ODE)


	Rule Procurence of
	alons of Commont Donatanaling1. 1. 1. 1. 1. 1.
3125	K041554

	D-2

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.