(121 days)
No
The document describes a laser system with a specific wavelength and handpieces, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is intended for the treatment of back acne, which is a therapeutic purpose.
No
The ARAMIS II Dermatological Laser system is intended for the treatment of back acne, which is a therapeutic rather than diagnostic purpose. It emits a laser for treatment, not for obtaining diagnostic information or images.
No
The device description explicitly states it is a laser system that emits a beam of coherent light and includes hand pieces, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ARAMIS II Dermatological Laser system is a therapeutic device that uses a laser to treat back acne. It directly interacts with the patient's skin.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples. The device delivers energy to the body, rather than analyzing something taken from the body.
Therefore, based on the provided information, the ARAMIS II Dermatological Laser system is a therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ARAMIS II Dermatological Laser system, in addition to previously cleared indications, is intended for the treatment of back acne.
The Aramis II Dermatological Laser system is intended for the treatment of back acne.
Product codes
GEX
Device Description
The ARAMIS II Dermatological Laser emits a beam of coherent light at 1540 nms which is delivered to the hand pieces, including a cooling hand piece, through a fiber optic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back
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)
None required; the ARAMIS II claims substantial equivalence to the Candela Smoothbeam based on comparisons of specifications/characteristics and indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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K032260 1 of 2
ATTACHMENT #3
NOV 2 0 2003
SECTION 9
510(k) SUMMARY
This 510(k) summary of safety and effectiveness for the ARAMIS II Dermatological Laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | Quantel Medical |
|---|---|
| Address: | QUANTEL MEDICAL |
| 21 rue Newton | |
| ZI du BREZET | |
| 63039 Clermont-Ferrand | |
| Cedex 2 | |
| FRANCE | |
| +33 (0)473 745 745 | |
| +33 (0)473 745 700 (Fax) | |
| Contact Person: | Mr. Jean Abascal |
| (+33) 169 29 17 25 | |
| (+33) 169 29 17 29 | |
| Preparation Date: | |
| (of the Summary) | July 2003 |
| Device Name: | ARAMIS II Dermatological Laser |
| Common Name: | Er:Glass Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in |
| dermatology (see: 21 CFR 878.4810). | |
| Product Code: GEX | |
| Panel: 79 | |
| Predicate devices: The Smoothbeam Laser System - K014128 | |
| Device description: The ARAMIS II Dermatological Laser emits a beam of coherent light at | |
| 1540 nms which is delivered to the hand pieces, including a cooling hand | |
| piece, through a fiber optic. | |
| Indications: | The ARAMIS II Dermatological Laser system, in addition to previously |
| cleared indications, is intended for the treatment of back acne. |
1
K032260 2 of 2
- Performance Data: None required; the ARAMIS II claims substantial equivalence to the Candela Smoothbeam based on comparisons of specifications/characteristics and indications for use
- CONCLUSION: Based on the information in this notification Quantel Medical concludes that the ARAMIS II, indicated for the treatment of back acne, is substantially equivalent to the Candela Smoothbeam.
rev. August 15, 2003
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 image of three human profiles facing right, layered on top of each other, suggesting a sense of community and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2003
Quantel Medical c/o Mr. Roger W. Barnes 342 Sunset Bay Road Hot Springs, Arkansas 71913
Re: K032260
Trade/Device Name: Aramis II Dermatological Laser - New Indication 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: October 22, 2003 Received: October 28, 2003
Dear Mr. Barnes:
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. Roger W. Barnes
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,
Muriam C. Provost
O 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
SECTION 7
INDICATIONS FOR USE STATEMENT
K032260 510(k) Number (if known):
Device Name: Aramis II Dermatological Laser - New indication
Indications for Use Statement:
The Aramis II Dermatological Laser system is intended for the treatment of back acne.
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032260
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ... Concurrence of CDRH, Office of Device Evaluation
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The Counter Use ________________________________________________________________________________________________________________________________________________________