The SLIM Evolution Family of CO2 Lasers and delivery device accessories are intended for use in surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

Dermatology, Plastic Surgery and General Surgery procedures including but not limited to -

Laser skin resurfacing

Treatment of furrows and wrinkles

Removal of skin tags, actinic keratosis, acne scars, keloids, tattos,

telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation.

Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications. Blepharoplasty

Site preparation for hair transplants

Dental procedure including but not limited to -

Periodontal procedures such as -- gingivectomy, removal of hyperplasias,gingivoplasty (incision and excision) Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign/malignant lesion ablation, operculectomy and homeostasis

Podiatry procedures including but not limited to -

Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.

Otorhinolaryngology (ENT) procedures including but not limited to -

Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps.

Gynecology

Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia. Laparoscopic treatment endometrial lesions, ablation of endometriosis, fimbroplasty,

Tubal microsurgery, salpingostomy, histerectomy, uterine myomas and fibroids

Device Description

The SLIM Evolution Family of CO2 Lasers emit a beam of coherent light at the wavelength 10.6 microns in either continuous wave or pulse mode. Each laser consists of a self-contained console, an articulated arm delivery system, a footswitch, safety goggles and warning label set. The main console contains a DC-excited sealedoff CO2 gas tube, micro-controller, articulated arm mount, internal closed circuit cooling system and power supply. The console has an on-off key switch and emergency stop push button. The articulated arm connects the console to focusing handpieces, waveguides, scanner and micromanipulator delivery accessories. Refer to the enclosed brochure and instruction manual for complete published information.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

The provided document does not specify quantitative acceptance criteria or provide
performance metrics for the SLIM Evolution Family of CO2 Lasers. The submission states
"Performance Data: None provided" and "Clinical Data: None provided."
Therefore, a table of acceptance criteria and reported device performance cannot be
generated from the provided text.
Sample Size Used for the Test Set and Data Provenance:

Not applicable. The document explicitly states "Performance Data: None provided" and
"Clinical Data: None provided." This indicates that no specific test set data was
used or presented for the device's performance evaluation in the 510(k) submission.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. As no performance or clinical data was provided, no ground truth
establishment for a test set was conducted or reported in this submission.
Adjudication Method for the Test Set:

Not applicable. No test set or associated adjudication method was mentioned or
described in the provided document.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. The document concerns a CO2 laser device for surgical
applications, not an AI-powered diagnostic or assistive technology for human readers.
Therefore, an MRMC study related to AI assistance is irrelevant to this submission.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The device is a physical CO2 laser system, not an algorithm.
Standalone algorithmic performance is not relevant to this type of medical device submission.
The Type of Ground Truth Used:

Not applicable. No performance or clinical data was provided, so no type of ground
truth was used or documented in this submission. The device's substantial
equivalence was based on comparison to legally marketed predicate devices, not on
independent performance testing against a defined ground truth.
The Sample Size for the Training Set:

Not applicable. The device is a physical CO2 laser system. There is no mention of a
training set in the context of machine learning or algorithm development.
How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an algorithm, the establishment of
ground truth for such a set is not relevant to this submission.

Summary

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

510(k) Summary of Safety and Effectiveness for the SLIM Evolution Family of CO2 Lasers and Delivery Device Accessories

KOG3001

MAR 0 7 2007

General Information 1.

Submitter:	Lasering S.r.lVia Staffette Partigiane, 54Modena, 4110 Italy
------------	----------------------------------------------------------------------

Contact Person: Allen R. Howes TTI Medical 2246 Camino Ramon San Ramon, CA 94583 925-355-0750 (F) 925-355-0777

Preparation Date: September 25, 2006

2. Device Name:

Trade/Proprietary Name: SLIM Evolution Family of CO2 Lasers and Delivery Device Accessories Common/Usual Name: General Surgical Laser System Classification Name: Laser Instrument, Surgical Powered Product Code: GEX Panel: 79

3. Predicate Devices:

The SLIM Evolution Family of CO2 Lasers are substantially equivalent the predicate devices Aesculap-Meditec Multipulse (K002032), Coherent Ultrapulse 2500C (K963339) and Lumenis Ltd.(formerly Sharplan Lasers Inc) Model 20C, 30C and 40C Surgical Lasers (K963229).

The SLIM Evolution Delivery Device Accessories are substantially equivalent to predicate delivery devices - Sharplan focused spot handpieces with reusable tip accessories (K933918) - Sharplan fiber/waveguide handpieces (K900076 and K950725) - Sharplan Scanner devices - K955621, K960521 and K963339) - Sharplan micromaniplutors - (K933918, K881953 and K951204).

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

Device Description: 4.

ડ. Intended Use:

Performance Data: None provided 6.

1. Clinical Data: None provided

8. Conclusion:

The SLIM Evolution Family of CO2 Lasers and delivery device accessories are substantially equivalent to predicate CO2 laser systems in commercial distribution for use in Dermatology, Plastic Surgery, General Surgery, Dental, Podiatry, Otorhinolaryngology and Gynecology.

{2}------------------------------------------------

Indications for Use

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Device Name: SLIM Evolution Family of CO2 Lasers and Delivery Device Accessories.

Indications For Use: Continued from previous page

Dental procedure including but not limited to -

Podiatry procedures including but not limited to -

Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.

Otorhinolaryngology (ENT) procedures including but not limited to -

Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps.

Gynecology

Tubal microsurgery, salpingostomy, histerectomy, uterine myomas and fibroids

Prescription Use X (part21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use -------------------------------------------(21 CFR 801 Subpart C)

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

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

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lasering S.R.L. % TTI Medical Mr. Allen R. Howes President 2246 Camino Ramon San Ramon, California 94583

MAR 0 7 2007

Re: K063001

Trade/Device Name: SLIM Evolution Family of CO2 Lasers and Delivery Device Accessories 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: February 27, 2007 Received: February 28, 2007

Dear Mr. Howes:

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

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

Page 2 – Mr. Allen R. Howes

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.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

for

Mark N. Melkonian

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Device Name: SLIM Evolution Family of CO2 Lasers and Delivery Device Accessories.

Indications For Use:

Dermatology, Plastic Surgery and General Surgery procedures including but not limited to -

Laser skin resurfacing

Treatment of furrows and wrinkles

Removal of skin tags, actinic keratosis, acne scars, keloids, tattos,

telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation.

Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications. Blepharoplasty

Site preparation for hair transplants

AND/OR Over-The-Counter Use Prescription Use (21 CFR 801 Subpart C) (part 21 CFR 801 Subpart D)

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

(Division Sign-Off) Division of General. Restorative, and Neurological Devices 7-3

Page 1 of 2

510(k) Number `/K063001

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.