(213 days)
Not Found
No
The description focuses on the laser technology and its adjustable parameters, with no mention of AI or ML.
Yes
The device is described as a medical laser system used for various surgical applications, including incision, excision, ablation, vaporization, and coagulation of tissues, which are all therapeutic procedures.
No
The "Intended Use / Indications for Use" section mentions "diagnostic biopsy" as one of the procedures for which the device is indicated. While a biopsy is a step often taken for diagnostic purposes, the device itself is used for the physical act of taking the biopsy (incising, excising) and not for analyzing the gathered tissue or producing a diagnosis. The "Device Description" also focuses on its physical actions (incise, excise, ablate) and none of the other sections suggest diagnostic capabilities.
No
The device description clearly details a physical laser system with hardware components like a handpiece, fiber optics, and adjustable settings for power, pulse duration, and flow rates. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
- The description of this device clearly states its intended use is for directly treating tissues on or within the body through incision, excision, ablation, vaporization, and coagulation. It's a surgical laser system.
The device description and intended use focus on performing procedures on the patient, not analyzing samples from the patient.
N/A
Intended Use / Indications for Use
Use of the device is indicated for the incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing.
Use of the device is further indicated for the incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision. tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.
Product codes
79 GEX, MXF, DZI
Device Description
The Waterlase®MD Derm medical laser system is a device used to perform a variety of soft tissue indications. Soft tissue procedures are performed using a different mode of operation where direct Er.Cr. YSGG laser energy is applied to incise, excise or ablate these tissues. For soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues and the field of view clean.
fiber optic terminated into the handpiece delivers flexible ব the Waterlase®MD Derm laser energy to the end fiber tip and target. A visible aiming light emitted from the handpiece's distal end pinpoints the area of treatment. Three fiber optic ports provide illumination from the handpiece to the tissue site in addition to the center beam emitting source. In soft tissue applications the power output, pulse duration, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. The spot size and spot geometry can also be varied by changing tips which include different diameters and end configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dermatologic tissues, soft tissue.
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)
Millenium™, DermaLase™, MCL 30 Dermablate
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
K071734
510(k) Summary of Safety and Effectiveness Information
| Regulatory Authority: | Safe Medical Devices Act of 1990,
21 CFR 807.92 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Company: | BioLase Technology, Inc.
4 Cromwell
Irvine, CA 92618 |
| Contact: | Ms. Ioana M. Rizoiu
BioLase Technology, Inc.
4 Cromwell
Irvine, CA 92618
Tel: (949) 226-8144
Fax: (949) 273-6680 |
| Trade Name: | Waterlase® MD Derm |
| Common Name: | Er,Cr:YSGG laser |
| Classification Name: | Surgical laser instrument |
| Classification Code: | 79 GEX, MXF, DZI a Class II device |
| Equivalent Devices: | Millenium™
DermaLase™
MCL 30 Dermablate
Biolase Technology, Inc.
Endo Technic Corp.
Asclepion Laser Technologies |
Device Description:
The Waterlase®MD Derm medical laser system is a device used to perform a variety of soft tissue indications. Soft tissue procedures are performed using a different mode of operation where direct Er.Cr. YSGG laser energy is applied to incise, excise or ablate these tissues. For soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues and the field of view clean.
fiber optic terminated into the handpiece delivers flexible ব the Waterlase®MD Derm laser energy to the end fiber tip and target. A visible aiming light emitted from the handpiece's distal end pinpoints the area of treatment. Three fiber optic ports provide illumination from the handpiece to the tissue site in addition to the center beam emitting source. In soft tissue applications the power output, pulse duration, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. The spot size and spot geometry can also be varied by changing tips which include different diameters and end configurations.
1
Indications for Use:
Use of the device is indicated for the incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing.
Use of the device is further indicated for the incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision. tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.
Cautions, Precautions and Contraindications;
All clinical procedures performed with Waterlase® MD Derm must be subject to the same clinical judgment and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment. Exercise caution for general medical conditions, which might contraindicate a local procedure. Such conditions may include, but are not limited to, allergy to local or topical anesthetics, heart disease, bleeding disorders, sleep apnea or an immune system deficiency. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.
Substantial Equivalence:
The indications included herein are the same as indications that have been previously cleared by the FDA for other devices. Substantial equivalency for the Waterlase®MD Derm has been determined through comparison to previously cleared devices.
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 an abstract symbol that resembles a stylized caduceus or a representation of human figures.
JAN 2 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biolase Technology, Inc. % Ms. Ioana Rizoiu VP. Clinical Research and Development 4 Cromwell Irvine, California 92618
Re: K071734
Trade/Device Name: Waterlase® MD Derm 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 29, 2007 Received: October 30, 2007
Dear Ms. Rizoiu:
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
3
Page 2 - Ms. Ioana Rizoiu
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistances e 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.
Mark M. Mikkelsen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K071734
Device (Trade) Name: Waterlase® MD Derm
Indications for Use:
- Use of the device is indicated for the incision, excision, ablation, vaporization and . coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of turnors, cysts, diagnostic biopsy and skin resurfacing.
- Use of the device is further indicated for the incision, excision, vaporization and . coagulation of soft tissue during general surgical applications where skin incision, tissue disection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use_ (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. Milheron
(Division Sign-Off) (Division Biggeral, Restorative, and Neurological Devices
510(k) Number