(44 days)
No
The provided text describes a laser device for soft tissue surgery and does not mention any AI or ML capabilities.
Yes
The device is used for various medical and cosmetic surgical procedures, including excision, incision, and coagulation of soft tissues, as well as specific oral procedures like gingivectomy and treatment of aphthous ulcers, which are therapeutic interventions.
No
The provided text explicitly states the device's purpose is for surgical procedures such as ablating, incising, excising, vaporizing, and coagulating soft tissues, as well as light activation for teeth whitening. There is no mention of it being used to identify or diagnose medical conditions or diseases.
No
The intended use and device description (although not fully provided) clearly describe a device that performs physical actions (ablating, incising, excising, vaporizing, coagulation) using a contact fiber optic delivery system. This indicates a hardware component is essential to the device's function, not just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures on soft tissues within the body (intraoral soft tissue maxilla-facial dental, general, oral, and cosmetic surgery). It involves ablating, incising, excising, vaporizing, and coagulating tissue.
- IVD Definition: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests on samples.
- Device Description and Other Sections: The provided information lacks any mention of analyzing biological samples, image processing for diagnostic purposes, AI/ML for diagnosis, or input imaging modalities typically associated with diagnostic devices. The anatomical site is within the body, not a sample taken from the body.
Therefore, the SoftLase Pro™/OrthoLase™/HygieneLase™ is a surgical laser device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SoftLase Pro™/OrthoLase™/HygieneLase™ is to provide the ability to perform intraoral soft tissue maxilla-facial dental. general, oral and i cosmetic surgery. The SoftLase ProTM/OrthoLase™/HygieneLase™ is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system.
The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharneeal indications for use for which the device will be marketed:
-Excision and Incision Biopsies
-Hemostatic assistance
-Treatment of Apthous Ulcers
-Frenectomy
-Frenotomy
-Gingival Incision and Excision
-Gingivectomy
-Gingivoplasty
-Incising and Draining of Abscesses
-Operculectomy
-Oral Papillectomy
-Removal of Fibromas
-Soft Tissue Crown Lengthening
-Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
-Tissue retraction for Impression
-Vestibuloplasty
-Light activation of bleaching materials for teeth whitening
-Laser-assisted bleaching/whitening of teeth
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral soft tissue maxilla-facial dental, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, genecology, urology, opthamology and pulmonary surgery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities, physicians and dentists.
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
Safety and performance testing.
Key Metrics
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.
0
SoftLase Pro OrthoLase HygieneLase 510K
CONFIDENTIAL
KC091796
JUL 81 2009
Appendix D PREMARKET NOTIFICATION |510(k)] Summary
510(K) Summary of Safety and Effectiveness Premarket Notification 510(k)
Zap Lasers, LLC 2621-B Pleasant Hill Road Pleasant Hill, Ca. 94523
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
1. Device Name:
SoftLase Pro/OrthoLase/HygieneLase family of products Trade Name: Common Name(s): Surgical Laser System Classification Name(s): Laser, Surgical
- Establishment Name & Registration Number: Name: Zap Lasers, LLC Number: 3005212363
3. Classification(s):
$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 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. Class II.
| Device Class: | Class II for all requested indications |
|---|---|
| Classification Panel: | General and Plastic Surgery & Others |
| Product Code(s): | GEX |
.
4. Section 514 Compliance
Zap Lasers, LLC intends to comply fully with the general controls authorized under Sections 501, 502, 510, 516, 518, and 520 of the Food, Drug, and Cosmetic Act.
1
5. Performance Standards
United States Food and Drug Administration mandated performance standards for this device exist and are provided under Sections 21 CFR 1010 & 1020, with permissible deviations relative to Laser Notice 50, dated July 26, 2001. The device also complies with IEC60601-1:1995+A1+A2, IEC60601-2-22:1995, and IEC60825-1:1993+A1+A2. In addition, various voluntary performance standards are utilized. Voluntary standards utilized include Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and cGMP & ISO 9000 series quality regulations.
6. Special Controls:
All Class II devices are subject to Special Controls.
7. Labeling:
.
The laser system discussed in this premarket notification will be manufactured by Zap Lasers, LLC and labeled as such. Zap Lasers, LLC will market the system exclusively to healthcare facilities, physicians and dentists. In addition to the usual package and identification labeling, the following additional Warnings, Cautions & Precautions statements are displayed as appropriate on or within the device packaging. They are repeated here for ease of use.
Warning: Federal (United States) Law restricts this device to sale by or on the order of a physician or dentist only.
9. Predicate Device (legally marketed comparison device)
Zap Lasers, Inc. believes that the following surgical laser systems are substantially equivalent to the SoftLase Pro/OrthoLase/HygieneLase Family of products surgical diode system.
-
- SoftLase G2 (K021227, Zap Lasers, LLC)
-
- ODYSSEY NAVIGATOR (K062258, Ivoclar Vivadent, Inc.)
-
- STYLA MICROLASER/STYLAORTHO Diode Laser System (K081214, Zap Lasers LLC.)
10. Summary of Equivalence:
There are no unique applications, material or specifications presented herein. Evidence of equivalence has been demonstrated through:
- The SoftLase Pro ™/OrthoLase™/HygieneLase™ family of products intended use and indications . for use were previously cleared by FDA for the predicate devices.
- The technical characteristics of the SoftLase Pro ™/OrthoLase™/HygieneLase™ family of products . are similar to those of the cleared SoftLase G2, Odyssey Navigator and the Styla MicroLase.
- Laser output values of the SoftLase Pro ™/OrthoLase™/HygieneLase™ family of products are well . within previously cleared values of the predicate dental laser system as described.
- The predicate devices and other previously cleared laser systems with similar power outputs have a . proven safety and effectiveness in the treatment of the claimed indications.
- . Safety and performance testing.
Therefore, the SoftLase Pro/OrthoLase Family of products is substantially equivalent to its predicate devices cited above and raises no new safety and/or effectiveness issues.
Page 46 of 72
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ZAP LASERS, LLC % Mr. Jay Goble, DDS President 2621-B Pleasant Hill Road Pleasant Hill, California 94523
JUL 3 1 2009
Re: K091796
Trade/Device Name: Softlase Pro™/OrthoLase™/HygieneLase™ 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: July 15, 2009 Received: July 22, 2009
Dear Mr. Goble:
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. Iisting 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Jay Goble, DDS
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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, Mark N.Melkerso Director Division of Surgical, Orthopedic and Restorative Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CONFIDENTIAL
Tab 2 Indications for Use Statement
Device Name: SoftLase Pro™/OrthoLase™/HygieneLase™
Indication for Use:
The SoftLase Pro™/OrthoLase™/HygieneLase™ is to provide the ability to perform intraoral soft tissue maxilla-facial dental. general, oral and i cosmetic surgery. The SoftLase ProTM/OrthoLase™/HygieneLase™ is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system.
The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharneeal indications for use for which the device will be marketed:
-Excision and Incision Biopsies
-Hemostatic assistance
-Treatment of Apthous Ulcers
-Frenectomy
-Frenotomy
-Gingival Incision and Excision
-Gingivectomy
-Gingivoplasty
-Incising and Draining of Abscesses
-Operculectomy
-Oral Papillectomy
-Removal of Fibromas
-Soft Tissue Crown Lengthening
-Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
-Tissue retraction for Impression
-Vestibuloplasty
-Light activation of bleaching materials for teeth whitening
-Laser-assisted bleaching/whitening of teeth
| Prescription Use | X |
|---|---|
| (21 CFR Part 801 Subpart D) | |
| And/Or | |
| Over the Counter Use | . |
| (21 CFR Part 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
| (Division Sign-Off) |
|---|
Division of Surgical, Orthopedic, and Restorative Devices
Page 6 of 72
6/15/09
510(k) Number K091796