(69 days)
Not Found
No
The device description focuses on the hardware components and basic laser functionality, with no mention of AI or ML algorithms for image processing, data analysis, or automated control.
Yes
The device explicitly states its intended use for various surgical procedures, as well as treatment of medical conditions like aphthous ulcers and sulcular debridement, and teeth whitening, all of which aim to restore or improve health and function.
No
The device description indicates that the SoftLase G2 is a surgical laser system used for ablating, incising, excising, vaporization, and coagulation of intraoral soft tissues, as well as for teeth whitening procedures. These are all therapeutic or procedural functions, not diagnostic.
No
The device description clearly outlines hardware components such as laser diode assemblies, power supplies, fiber cables, and a foot-switch, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the SoftLase G2 - Surgical Diode Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The SoftLase G2 is a surgical laser system used to perform procedures in vivo (within the body) on intraoral soft tissues. Its intended uses involve directly interacting with and modifying tissue within the patient's mouth and other anatomical sites.
The description clearly outlines a device for surgical procedures and teeth whitening, not for analyzing biological samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The SoftLase G2 - Surgical Diode Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The SoftLase G2 is intended for ablating, incising, excising, vaporization and coagulation intraoral soft tissues using a contact fiber optic delivery system. The system is also intended for use in teeth whitening procedures.
The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following are the 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
-Exposure of interrupted teeth
-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 (comma separated list FDA assigned to the subject device)
GEX
Device Description
The laser diode assembly with fiber bundle, which contains 3 single diode lasers, each of 1.6 watt output power (Class IV lasers) lasing at about 808 nm. Each diode laser is coupled directly into a 200 um core optical fiber using a special positioner. The assembly also contains a 5-mw power - 650 nm pilot laser diode, which is coupled into the three core fibers. In the second version of the device, a single 5 Watt laser diode is used. A special optical system is implemented to focus its laser diode radiation into a delivery fiber. It allows an effective use of 300 um and 200 um fibers. In both versions, a visible light of pilot laser is used for aiming the tip of the delivering fiber onto the tissue.
The laser diode power supply, with two controller PCBs supplies power to the diodes in DC or pulsed mode.
The delivery fiber cables, consist of multi-mode, single core optical fibers available in 200, 300, 400 and 600 um diameters. The standard SMA 905 fiber connector terminates one end of the delivery fiber, which is attached to the SMA union at the rear panel of the laser box. The other end of the fiber is stripped of its protective jacket and is cleaved to provide laser radiation output.
The foot-switch, is a standard (UL-approved) commercial foot-switch/pedal that provides handsfree ON/OFF capabilities. This controls initiation/termination of laser power from the distal end of the delivery fiber. Each SoftLase G2 laser system is provided with two safety goggles, one fiber stripper and one sapphire wedge scribe for fiber cleaving.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities, physicians and dentists
dental, general, oral maxillo-facial and cosmetic surgery for general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.
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)
Safety and performance testing.
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.
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
KO21227
Image /page/0/Picture/1 description: The image contains a handwritten fraction. The numerator appears to be a number that is partially cut off, but it looks like a "1". The denominator is the number "4". The numbers are written in a dark color, possibly black or dark brown, against a white background.
| Summary of Safety and Effectiveness Information | ZAP LASERS, LLC |
|---|---|
| Premarket Notification, Section 510(k) | APRIL 15, 2002 |
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
-
- Device Name:
SoftLase G2 - Surgical Diode Laser System Trade Name: Common Surgical Laser System Name(s): Classification Laser, Surgical Name(s):
- Device Name:
-
- Establishment Name & Registration Number: Name: ZAP LASER, LLC Number: applied/pending
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 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. Class II.
Class II for all requested indications Device Class: 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, 519, and 520 of the Food, Drug, and Cosmetic Act.
ડ Performance Standards
United States Food and Drug Administration mandated performance standards for this device exist and are provided under Sections 21 CFR 1010 & 1020. 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.
ZAP LASERS, LLC also meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.
6. Special Controls:
All Class II devices are subject to Special Controls.
SoftLase.doc
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21227 2/4
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 review.
Warning: Federal (United States) Law restricts this device to sale by or on the order of a physician or dentist only.
8. Summary Basis of Equivalence:
There are no unique applications, material or specifications presented herein. Evidence of equivalence has been demonstrated through:
- The SoftLase G2 intended use and indications for use were previously cleared by FDA for the . predicate devices.
- The technical characteristics of the SoftLase G2 are similar to those of the cleared SoftLase, . Aurora HL and Twilite lasers.
- Laser output values of the SoftLase G2 are well within previously cleared values of the predicate . dental laser systems 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 G2 Surgical Diode Laser System is substantially equivalent to its predicate devices cited above and raises now new safety and/or effectiveness issues.
9. Predicate Device (legally marketed comparison device)
Zap Lasers, Inc. believes that the following surgical laser systems are substantially equivalent to the SoftLase - Surgical Laser Diode System:
-
- SOFTLASE (K003440, ZAP Lasers, Inc.); 2. AURORA HL (K992374, Premier Laser Systems, Inc.) and 3. TWILITE (K003385, Biolase Technology, Inc.).
To assist in the overall evaluation of the referenced surgical laser systems, the following Feature Comparison Table presents a brief graphic illustration of the primary features.
- SOFTLASE (K003440, ZAP Lasers, Inc.); 2. AURORA HL (K992374, Premier Laser Systems, Inc.) and 3. TWILITE (K003385, Biolase Technology, Inc.).
| FEATURE | SoftLase G2 - Surgical Diode Laser System | SoftLase, Aurora HL & Twilite | SE? |
|---|---|---|---|
| Type of laser | Diode laser | Diode laser | YES |
| Wavelength | $808 \pm 5$ nm | $808 \pm 5$ nm (SoftLase); 810 nm (+ 170 | |
| nm, -30 nm) (Aurora HL); $815 \pm 15$ nm | |||
| (Twilite) | YES | ||
| Max output | |||
| power | 3.5 Watt | 3.5 Watt (SoftLase); 1.5 Watt (Aurora | |
| HL); 7 Watt (Twilite) | YES | ||
| Operation mode | Continuous wave and pulsed | Continuous wave and pulsed | YES |
| Delivery system | Multi-mode 400/600 um core quartz fiber | Multi-mode 400/600 um core quartz | |
| fiber | YES |
2
K621227 3,
| Fiber aiming
| beam | 5 mw diode laser, 650 nm | 5 mw diode laser, 650nm | YES |
|---|---|---|---|
| Activation means | Foot-switch | Foot-switch | YES |
| Intended Use and | |||
| Indications for | |||
| Use | -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 | |||
| -Exposure of unerupted teeth | |||
| -Soft Tissue Crown Lengthening | |||
| -Sulcular Debridement (removal of diseased | |||
| or inflamed soft tissue in the periodontal | |||
| pocket) | |||
| -Tissue retraction for Impression | |||
| -Vestibuloplasty | Same | YES | |
| -Light activation of bleaching materials for | |||
| teeth whitening | |||
| -Laser-assisted bleaching / whitening of | |||
| teeth | Same | YES |
10. Device Description:
The laser diode assembly with fiber bundle, which contains 3 single diode lasers, each of 1.6 watt output power (Class IV lasers) lasing at about 808 nm. Each diode laser is coupled directly into a 200 um core optical fiber using a special positioner. The assembly also contains a 5-mw power - 650 nm pilot laser diode, which is coupled into the three core fibers. In the second version of the device, a single 5 Watt laser diode is used. A special optical system is implemented to focus its laser diode radiation into a delivery fiber. It allows an effective use of 300 um and 200 um fibers. In both versions, a visible light of pilot laser is used for aiming the tip of the delivering fiber onto the tissue.
The laser diode power supply, with two controller PCBs supplies power to the diodes in DC or pulsed mode.
The delivery fiber cables, consist of multi-mode, single core optical fibers available in 200, 300, 400 and 600 um diameters. The standard SMA 905 fiber connector terminates one end of the delivery fiber, which is attached to the SMA union at the rear panel of the laser box. The other end of the fiber is stripped of its protective jacket and is cleaved to provide laser radiation output.
The foot-switch, is a standard (UL-approved) commercial foot-switch/pedal that provides handsfree ON/OFF capabilities. This controls initiation/termination of laser power from the distal end of the delivery fiber. Each SoftLase G2 laser system is provided with two safety goggles, one fiber stripper and one sapphire wedge scribe for fiber cleaving.
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021227 4/4
11. Applicant Name & Address:
Zap Lasers, LLC 2643 Pleasant Hill Road Pleasant Hill, CA 94523
12. Company Contact:
Jay Goble, DDS Zap Lasers, LLC 2643 Pleasant Hill Road Pleasant Hill, CA 94523 Phone: 888-876-4546 925-692-2063 Fax:
13. Submission Correspondent:
Jav Goble, DDS Zap Lasers, LLC 2643 Pleasant Hill Road Pleasant Hill, CA 94523 Phone: 888-876-4546 925-692-2063 Fax:
14. Manufacturing Facility:
The devices are physically manufactured at ZAP Laser, LLC premises in Pleasant Hill, CA. The devices are manufactured by Zap Lasers, LLC for distribution in the U.S.A.
15. Sterilization, Packaging & Storage Information:
The diode laser device is not supplied sterile. The hand-piece, which secures the working end of the fiber, is sterilizable as well as fiber itself. The plastic canula, which is attached to the handpiece and fixes the position of fiber tip is disposable. A special disinfecting protocol is developed for fiber stripping/cleaving.
Packaging materials are typical medical grade tubes, plastic trays, peel-type pouches of the generic mylar/non-woven sandwich variety, etc. All packages should be intact upon receipt. Packaging should be inspected on arrival for evidence of shipping damage. Damaged packaging may indicate the presence of unsafe product and it should not be used until carefully inspected. If the package or product is damaged, the product should not be used and should be returned. Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or contamination. When used, the product must be placed into use following cleaning, sterilization and accepted surgical sterile technique.
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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus with three intertwined snakes and a bowl. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2002
Zap Lasers, LLC Jav Goble, DDS President 2643 Pleasant Hill Road Pleasant Hill, California 94523
Re: K021227
Trade Name: Softlase G2-Surgical Diode Laser System Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Regulatory Class: II Product Code: GEX Dated: April 15, 2002 Received: April 18, 2002
Dear Dr. Goble:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 mav 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.
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Page 2 - Dr. Jay Goble
This letter will allow you to begin marketing your device as described in your Section 510(k) nremarket 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Stupt Rhodes
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
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Page 1 lof of of l
510(k) Number: K021227
SoftLase G2 - Surgical Diode Laser System Device Name(s):
Intended Use(s) of the Device:
The SoftLase G2 - Surgical Diode Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The SoftLase G2 is intended for ablating, incising, excising, vaporization and coagulation intraoral soft tissues using a contact fiber optic delivery system. The system is also intended for use in teeth whitening procedures.
The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following are the 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
-Exposure of interrupted teeth
-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
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Stut Rhodes
Prescription Use _ (Per 21 CFR 801.109) SoftLase.doc
(Division Sign-Off) Division of General, Restauries unter Use and Neurological Devices (Optional format 1-2-96)
KOZIZZ7 510(k) Number -
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