(156 days)
Not Found
No
The summary describes a standard CO2 laser system with a microcontroller for controlling the laser parameters. There is no mention of AI or ML in the intended use, device description, or any of the other sections.
Yes
The device is described as a CO2 laser intended for various surgical applications involving the ablation, vaporization, excision, incision, and coagulation of soft tissue, which signifies a direct medical intervention for treatment purposes.
No
This device is a CO2 laser system intended for surgical applications that require ablation, vaporization, excision, incision, and coagulation of soft tissue. These are all therapeutic actions, not diagnostic ones.
No
The device description explicitly details hardware components such as a console, articulated arm, footswitch, safety goggles, and a CO2 gas tube. It is a physical laser system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical applications involving the ablation, vaporization, excision, incision, and coagulation of soft tissue. These are direct surgical procedures performed on the patient's body.
- Device Description: The device description details a CO2 laser system designed to emit a light beam for surgical purposes. It describes the physical components of the laser and delivery system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside or on the body) for surgical treatment.
N/A
Intended Use / Indications for Use
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
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin, gingiva, oral cavity, nail, larynx, nasal, female reproductive organs (cervix, vulva, vagina, endometrium, fallopian tubes, uterus)
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)
Performance Data: None provided
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K002032, K963339, K963229, K933918, K900076, K950725, K955621, K960521, K963339, K933918, K881953, K951204
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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.l
Via Staffette Partigiane, 54
Modena, 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.
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.
ડ. Intended Use:
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.
Performance Data: None provided 6.
-
- 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 -
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
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:
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
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