(97 days)
K/DEN number and list them here in a comma separated list exactly as they appear in the text:
Not present in text.
Not Found
No
The summary describes a laser system for dermatological applications and does not mention any AI or ML components or functionalities.
Yes
The document states the device is indicated for the treatment of medical conditions like acne and facial wrinkles, which are therapeutic applications.
No
The device is indicated for treatment (e.g., acne, facial wrinkles, hair reduction) rather than diagnosis.
No
The device description explicitly lists multiple hardware subsystems, including an Optical and Laser resonator System, Electronics and Electrical System, Delivery Devices and Accessories, and a Cooling Sub-system. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the Laserscope Gemini™ Laser System clearly indicate it is a therapeutic device that uses laser energy to treat various dermatological conditions (acne, wrinkles, hair reduction) directly on the patient's skin. It does not involve the analysis of specimens taken from the body.
Therefore, the Laserscope Gemini™ Laser System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
GEX
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 ●
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Laserscope Lyra™ G Laser System and Accessories, AURA i™ Surgical Laser System & Accessories, Laserscope Lyra™ Laser System and Accessories
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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
2 of 2
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body.
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.
3
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
4
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:
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.
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