(84 days)
,
Not Found
No
The device description focuses on the laser technology and its physical characteristics, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is described with indications for the treatment of various medical conditions, such as "ablation, incision, excision, coagulation and vaporization of tissue" and specific dental treatments like "frenectomy," "treatment of oral mucous cysts," and "treatment of canker sores, herpetic lesions, and aphthous ulcers." These actions directly address or alleviate a disease, injury, or condition, which aligns with the definition of a therapeutic device.
No
The provided text explicitly states the device's intended use is for "ablation, incision, excision, coagulation and vaporization of tissue," which are treatment procedures, not diagnostic ones.
No
The device description clearly states it is a frequency doubled Nd:YAG laser with a physical size and weight, electrical requirements, and a footswitch for activation, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device, the SmartLite D, is a laser used for surgical procedures directly on the patient's tissue (ablation, incision, excision, coagulation, vaporization).
- The intended use and device description clearly indicate a therapeutic and surgical function. There is no mention of analyzing samples or providing diagnostic information based on laboratory tests.
The SmartLite D is a surgical laser device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SmartLite D is indicated for ablation, incision, excision, coagulation and vaporization of tissue in ophthalmology, dermatology, ENT & dentistry.
The SmartLite D laser device is intended for ablation, incision, excision, vaporization and coagulation of soft tissue, in ophthalmology, ENT, and dermatology. In addition, the laser is intended for application in dentistry including:
- Frenectomy .
- Treatment of Oral Mucous Cysts .
- Treatment of Benign Vascular Lesions .
- Photocoagulation of Superficial Vessels .
- Vaporization of Superficial Blood Vessels or Lymphs Containing Vessels
- Treatment of Superficial Tongue Lesions .
- Tissue Management and Hemostasis for Crown and Bridge Impressions
- Incision and Drainage for Abscess .
- Gingivoplasty / Gingivectomy .
- Hemostasis during Dental Procedurcs .
- Operculectomy (Operculotomy) .
- Excisional Biopsy .
- Free Gingival Graft (Adjunct) .
- Vestibuloplasty .
- Soft Gutta Percha .
- Treatment of Canker sores, Herpetic Lesions, and Aphthous Ulcers
- Laser-assisted Bleaching / Whitening of the Teeth .
Product codes
GEX
Device Description
SmartLite D is a frequency doubled Nd:YAG laser, having a Nd:YAG crystal rod as the lasing medium. It is a laser with a wavelength of 532 nm. Laser activation is by footswitch. Overall weight of the laser is 10 Kg and the size is 27x26x36 cm (HxWxD). Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.
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
Nonclinical Performance Data: none
Clinical Performance Data: none
Key Metrics
Not Found
Predicate Device(s)
Fisma Elite Family of Lasers, frequency doubled Nd:YAG, Fisma Dental 200, Dental 300, Dental 400
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.
0
APR 3 0 2004
K 040289
510(K) Summary
| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, MA 01824 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior Vice President of Medical Technology |
| Date Summary Prepared: | February 5, 2004 |
| Device Trade Name: | SmartLite D Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | Fisma Elite Family of Lasers, frequency doubled Nd:YAG |
| | Fisma Dental 200, Dental 300, Dental 400 |
| Device Description: | SmartLite D is a frequency doubled Nd:YAG laser, having a Nd:YAG
crystal rod as the lasing medium. It is a laser with a wavelength of
532 nm. |
| | Laser activation is by footswitch. Overall weight of the laser is 10 Kg
and the size is 27x26x36 cm (HxWxD). |
| | Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase. |
| Intended Use: | The SmartLite D is indicated for ablation, incision, excision,
coagulation and vaporization of tissue in ophthalmology, dermatology,
ENT & dentistry. |
| Comparison: | The SmartLite D laser has an equivalent indication for uses, the same
principle of operation, the same wavelength and essentially the same
pulse energy range as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The SmartLite D laser is another safe and effective device for the
intended uses. |
| Additional Information: | none |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure embracing a globe, symbolizing the department's mission to protect and promote the health and well-being of Americans.
Public Health Service
APR 3 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K040289 Trade/Device Name: SmartLite D Laser 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 5, 2004 Received: February 6, 2004
Dear Mr. Cho:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(x) proxice is substantially equivalent (for the indications felerenced above and nave uctorinmed the end predicate devices marketed in interstate for use stated in the enclosure) to regard cate of the Medical Device Amendments, or to commerce proof to May 20, 1976, the eccordance with the provisions of the Federal Food, DINEA devices that have tocer recuire approval of a premarket approval application (PMA). alla Cosmetic Act (Tec) that as novements with the general controls provisions of the Act. The 1 ou may, dierelore, market the act include requirements for annual registration, listing of general controls provincies practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it n your device to such additional controls. Existing major regulations affecting your device can may oe sunyeet to back as 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 r lease be as made a determination that your device complics with other requirements of the Act than + Direcal statutes and regulations administered by other Federal agencies. You must or any I 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 OFF rate 8075 https://www.bg (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. George Cho
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,
Sincerely yours,
Mark A. Melkersen
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
3
Indications for Use
04028 510(k) Number (if known):
Device Name: SmartLite D Laser
Indications For Use: The SmartLite D laser device is intended for ablation, incision, excision, vaporization and coagulation of soft tissue, in ophthalmology, ENT, and dermatology. In addition, the laser is intended for application in dentistry including:
- Frenectomy .
- Treatment of Oral Mucous Cysts .
- Treatment of Benign Vascular Lesions .
- Photocoagulation of Superficial Vessels .
- Vaporization of Superficial Blood Vessels or Lymphs Containing Vessels ●
- Treatment of Superficial Tongue Lesions .
- Tissue Management and Hemostasis for Crown and Bridge Impressions ◆
- Incision and Drainage for Abscess .
- Gingivoplasty / Gingivectomy .
- Hemostasis during Dental Procedurcs .
- Operculectomy (Operculotomy) .
- Excisional Biopsy .
- Free Gingival Graft (Adjunct) .
- Vestibuloplasty .
- Soft Gutta Percha .
- Treatment of Canker sores, Herpetic Lesions, and Aphthous Ulcers �
- Laser-assisted Bleaching / Whitening of the Teeth .
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
Mark A. Millman
(Division S Division of General. Restorative, and Neurological Levices
510(k) Number K040284