(185 days)
Not Found
No
The provided text does not mention AI, ML, deep learning, neural networks, or any related concepts. The device description focuses on hardware components and the intended uses are described in terms of laser wavelengths and their effects on tissue.
Yes
The device is described as being used for the "treatment of periorbital and perioral wrinkles" and for "permanent hair reduction", which are therapeutic applications. Additionally, it lists "coagulation and hemostasis of vascular lesions" and "incision/excision of soft body tissues" as intended uses, which also constitute therapeutic interventions.
No
The device's intended use is for surgical and aesthetic applications, specifically for hair reduction, removal of vascular lesions, incision/excision of soft tissues, and treatment of wrinkles. These are all interventional or treatment-oriented uses, not diagnostic ones.
No
The device description explicitly lists multiple hardware components including a console (with laser, electronics, and cooling system), control panel, handpiece, skin cooling device, foot pedal, and remote interlock connector. This is not a software-only device.
Based on the provided information, the LucentLite Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information about a person's health. This testing is done outside of the body (in vitro).
- LucentLite Laser Function: The LucentLite Laser is a medical device that uses laser energy to directly interact with soft tissue on the human body for surgical and aesthetic purposes. It performs procedures on the patient, not on samples taken from the patient.
- Intended Use: The intended uses listed (hair reduction, vascular lesion coagulation, tissue incision/excision, wrinkle treatment) are all procedures performed directly on the patient's body.
- Device Description: The components described (console, handpiece, cooling device, foot pedal) are typical of a laser system used for direct treatment, not for analyzing biological samples.
Therefore, the LucentLite Laser falls under the category of a therapeutic or surgical medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LucentLite Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology:
1064 nm:
- To effect stable long-term, or permanent* hair reduction through selective targeting of melanin in hair follicles.
- For the removal of unwanted hair.
- For coagulation and hemostasis of vascular lesions.
- For Incision/excision of soft body tissues in dermatology.
- For soft tissue general surgery applications: skin incision; tissue dissection; excision of external turnors and lesions; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation.
- Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after treatment regimen.
1320 nm:
- For the treatment of periorbital and perioral wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The LucentLite Laser is comprised of the following main components:
- Console (including laser, electronics, cooling system, and software);
- Control panel;
- Permanently attached fiberoptic-coupled handpiece;
- Skin cooling device;
- Foot pedal;
- Remote interlock connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, hair follicles, vascular lesions, periorbital, perioral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical specialties of general and plastic surgery and dermatology
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K022226, K003202, K014035, K022466
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
9. 510(k) Summary.
9.1. Submitter's identification.
- Industrial & Medical Design, Inc. - 2570 Corporate Pl., Suite E104 Monterey Park, CA 91754
- Yevgeniy Kuklin Contact person: -President
- Date Summary Prepared: September 26, 2003 -
9.2. Submitted device name.
| - Trade name: | LucentLite |
|---|---|
| - Classification name: | Laser Surgical Instrument, |
| 21 CFR § 878.4810 |
9.3. Identification of predicate devices.
| - | Company: | Altus Medical, Inc. |
|---|---|---|
| - | Device: | Family of Altus Medical CoolGlide Aesthetic |
| - | Lasers | |
| - | 510(k) | K022226, K003202 |
| - | Company: | CoolTouch Corporation |
| - | Device: | CoolTouch Nd: Y AG Laser System |
| - | 510(k) | K014035 |
| - | Company: | Sciton, Inc. |
| - | Device: | Profile 1320 Laser System |
| - | 510(k) | K022466 |
1
9.4. Device description.
The LucentLite Laser is comprised of the following main components:
- Console (including laser, electronics, cooling system, and software);
- Control panel;
- Permanently attached fiberoptic-coupled handpiece;
- Skin cooling device;
- Foot pedal;
- Remote interlock connector.
9.5. Intended use of the device.
The LucentLite Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology:
9.6. Rationale for Substantial Equivalence.
The LucentLite Laser shares the same general indications for use, similar design features, and functional features as predicated devices. Therefore, the technological differences between LucentLite Laser and predicated devices do not raise any new issues of safety, effectiveness, or performance of the product. We believe that LucentLite is substantially equivalent to the above legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to promote health, well-being, and human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is printed in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 1 2004
Ms. Angela Mallery President Industrial & Medical Design, Inc. 2570 Corporate Place, Suite E104 Monterey Park, California 91754
Re: K033072 Trade/Device Name: LucentLite 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: January 9, 2004 Received: January 12, 2004
Dear Mr. Kuklin:
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 - Ms. Angela Mallery
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
C
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
5. Indication for Use Statement.
Industrial & Medical Design Inc. Applicant: K033072 510(k) Number:
LucentLite. Device Name:
Indications for Use:
The LucentLite Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology:
1064 nm:
-
To effect stable long-term, or permanent* hair reduction through selective targeting of melanin in hair follicles.
-
For the removal of unwanted hair.
-
For coagulation and hemostasis of vascular lesions.
-
For Incision/excision of soft body tissues in dermatology.
-
For soft tissue general surgery applications: skin incision; tissue dissection; excision of external turnors and lesions; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation.
- Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after treatment regimen.
1320 nm:
- For the treatment of periorbital and perioral wrinkles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Miriam C. Provost
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K033072 |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter-Use (Optional Format 1-2-96) |