The Laserscope Gemini™ Laser System & Accessories is indicated for: KTP/532 Applications: Dermatology: To treat moderate inflammatory Acne vulgaris. ND:YAG/1064 Applications: Dermatology: For use in the Dermatological Applications for the treatment of facial wrinkles. It is also intended to effect stable long-term, or permanent hair reduction in skin types I - VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term, stable, reduction in the number of hairs re-growing after a treatment regimen.

Device Description

The Laserscope Gemini™ Surgical Laser System and Accessories consists of four major subsystems: The Optical and Laser resonator System. The Electronics and Electrical System Operator Interface. A variety of Delivery Devices and Accessories A Cooling Sub-system

AI/ML Overview

Acceptance Criteria and Study Details for Laserscope Gemini™ Surgical Laser System & Accessories

This document describes the acceptance criteria and supporting study details for the Laserscope Gemini™ Surgical Laser System & Accessories, based on the provided 510(k) summary.

The 510(k) summary does not contain specific acceptance criteria with performance metrics, nor does it detail a standalone clinical study to prove the device meets such criteria. Instead, the submission relies on the concept of substantial equivalence to legally marketed predicate devices.

Therefore, the "acceptance criteria" presented below are inferred from the stated claims of substantial equivalence and the device's intended uses. The "reported device performance" is essentially the claim that its performance is equivalent to the predicate devices for the specified indications.

1. Table of Acceptance Criteria and Reported Device Performance

Indication for Use	Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (Claimed via Substantial Equivalence)
KTP/532 Applications:
Dermatology: To treat moderate inflammatory Acne vulgaris.	Demonstrated effectiveness for treating moderate inflammatory acne vulgaris, equivalent to predicate devices.	The Gemini™ system, like the predicate devices, effectively treats moderate inflammatory acne vulgaris.
ND:YAG/1064 Applications:
Dermatology: For use in the Dermatological Applications for the treatment of facial wrinkles.	Demonstrated effectiveness for the treatment of facial wrinkles, equivalent to predicate devices.	The Gemini™ system, like the predicate devices, effectively treats facial wrinkles.
Dermatology: To effect stable long-term, or permanent hair reduction in skin types I - VI through selective targeting of melanin in hair follicles. (Permanent hair reduction defined as a long-term, stable, reduction in the number of hairs re-growing after a treatment regimen).	Demonstrated ability to achieve stable long-term or permanent hair reduction across skin types I-VI, equivalent to predicate devices, with evidence of long-term stable reduction in hair regrowth.	The Gemini™ system, like the predicate devices, achieves stable long-term or permanent hair reduction in skin types I-VI by targeting melanin in hair follicles, resulting in a long-term, stable reduction in hair regrowth.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not contain information about a test set or a dedicated study with a specific sample size. The submission relies on demonstrating substantial equivalence to predicate devices, rather than presenting new clinical study data with a test set. Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

As there is no new clinical study presented in the 510(k) summary, there is no information regarding experts used to establish ground truth.

4. Adjudication Method

Without a new clinical study or test set, there is no adjudication method mentioned in the summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The 510(k) summary does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on demonstrating equivalence of the device itself, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The Laserscope Gemini™ Surgical Laser System & Accessories is a physical medical device (laser system), not an AI algorithm. Therefore, a standalone performance study for an algorithm without human-in-the-loop performance is not applicable and not presented in this 510(k) summary.

7. Type of Ground Truth Used

Given the reliance on substantial equivalence, the "ground truth" for the device's efficacy is implicitly the established safety and effectiveness of the predicate devices for their respective indications. The summary does not refer to new pathology, expert consensus, or outcomes data specifically for the Gemini™ system in a standalone study.

8. Sample Size for the Training Set

The 510(k) summary does not refer to a training set. This is because the submission is for a physical medical device, not an AI/ML algorithm that would undergo a "training" phase with data.

9. How Ground Truth for the Training Set Was Established

As there is no training set for this type of device, this question is not applicable.

Summary

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MAR 3 0 2004

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510(k) Summary Statement For the Gemini™ G Surgical Laser System & Accessories

General Information

A. Trade Name Gemini™ Series Surgical Laser System
B. Common Name Laser Instrument, Surgical, Powered
C. Establishment Registration Number

2937094

D. Manufacturer's Identification
Laserscope 3070 Orchard Drive San Jose, CA 95134-2011 (800) 243-9384-ext. 6795 (408) 943-9630 FAX

Official Correspondent Paul Hardiman Manager, Regulatory Affairs/Clinical Affairs

ட். Device Classification
The Gemini Series Surgical Laser System has been specifically classified as a Class II medical device by the OB/GYN, General Plastic Surgery, and ENT Device Advisory Panels.
F. Performance Standards
The Gemini Series Surgical Laser System conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.
G. Predicate Devices:
- Laserscope Lyra™ G Laser System and Accessories .
- AURA i™ Surgical Laser System & Accessories .
- Laserscope Lyra™ Laser System and Accessories .

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K034011
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Product Description: H.

The Laserscope Gemini™ Surgical Laser System and Accessories consists of four major subsystems:

The Optical and Laser resonator System .
The Electronics and Electrical System ●
Operator Interface .
A variety of Delivery Devices and Accessories
A Cooling Sub-system ●
l. Indications For Use:

The Laserscope Gemini™ Laser System & Accessories is indicated for:

KTP/532 Applications:

Dermatology: To treat moderate inflamatory acne vulgaris:

ND:YAG/1064 Applications:

Dermatology: For use in the Dermatological Applications for the treatment of facial wrinkles. It is also intended to effect stable long-term, or permanent hair reduction in skin types I - VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term, stable, reduction in the number of hairs re-growing after a treatment regimen.

J. Rationale for Substantial Equivalence
The Laserscope Gemini Surgical Laser System and Accessories share the same indications for use, similar design features, functional features, and therefore are substantially equivalent to: the Laserscope Lyra G Surgical Laser System and Accessories; the Laserscope Aura "DL" Series Surgical Laser Systems (KTP/532, KTP/YAG™ and Nd: YAG/1064 Configurations);and, the Laserscope Lyra Laser System and Accessories. Details are provided in the Substantial Equivalence Section of this submission.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2004

Mr. Paul H. Hardiman Manager, Regulatory Affairs Laserscope 3070 Orchard Drive San Jose, California 95134

Re: K034011

Trade/Device Name: GEMINI™ Surgical Laser System & 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: December 22, 2003 Received: December 31, 2003

Dear Mr. Hardiman:

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 Revister.

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 rcquirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours.

Mark McMillan

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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INDICATIONS FOR USE STATEMENT

Page 1

510(k) Number:

K034011

GEMINI™ SURGICAL LASER SYSTEM & ACCESSORIES Device Name:

INTENDED USE:

The Laserscope Gemini™ Laser System & Accessories is indicated for:

KTP/532 Applications:

Dermatology: To treat moderate inflammatory Acne vulgaris.

ND:YAG/1064 Applications:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: or (per 21 CFR 801.109)

Over The-Counter-Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANJOTHER PAGE)

/ Mark A. Millman

Restorative, and Neurologic

K034011
Number

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.