(53 days)
Not Found
No
The device description and intended use are purely mechanical/optical, and there is no mention of AI, ML, or image processing.
Yes
The device is intended and indicated for use in surgical procedures such as incision, excision, ablation, or photocoagulation of soft tissue to treat various medical conditions across multiple specialties. These are therapeutic actions.
No.
The device's intended use is for surgical procedures, such as incision, excision, ablation, or photocoagulation of soft tissue, not for identifying the presence, nature, or extent of a disease or condition.
No
The device description explicitly states that the device is comprised of "tips" which are "short, hollow lightpipes of alumina ceramic or stainless steel." This describes physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "communicate the laser beam of a CO2 surgical laser to the target site for the incision, excision, ablation, or photocoagulation of soft tissue." This describes a surgical tool used directly on the patient's body for treatment.
- Device Description: The device is described as "short, hollow lightpipes of alumina ceramic or stainless steel that provide a variety of spot sizes to target tissue." This is a physical component used in a surgical procedure.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
The device is clearly intended for direct surgical intervention on a patient, which falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use is to communicate the laser beam of a CO₂ surgical laser to the target site for the incision, excision, ablation, or photocoagulation of soft tissue. Representative examples of indications for use:
Gynecology-excision and vaporization of cervical, vulvar, and perineal condyloma; ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization; vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts.
Dermatology - port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratosis, actinic keratosis and actinic cheilitis.
Dentistry/Oral Surgery - gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors
General Surgery – hemorrhoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of deciditus ulcers and stasis ulcers; mastectomy; breast biopsy, reduction mammoplasty; cyto-reduction for metastatic disease; many dermatological procedures.
Laparoscopic surgery - vaporization, incision, excision, ablation, or photo-coagulation of soft tissue such as endometriosis ablation, excision of adhesions, salpingotomy.
Otorhinolaryngology - lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsillectomy, removal of vocal cord papillomas, nodules, and polyps.
Podiatry - plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neuroma removal; ingrown toenail treatment
Orthopedic - menisectomy, chondromalacia ablation, partial synovectomy, lateral release, PMMA removal
No new indications for use are sought beyond those associated with the predicate device.
Product codes
GEX
Device Description
These tips are short, hollow lightpipes of alumina ceramic or stainless steel that provide a variety of spot sizes to target tissue when utilized in a mating laser handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical, vulvar, perineal, vaginal, urethral, Bartholin's, nubothian, skin, breast, soft tissue, gingiva, frenum, lymphangioma, turbinectomy, subglottic, tonsil, vocal cord, papillomas, nodules, polyps, plantar, fungal nail, meniscus, chondromalacia, synovium, PMMA, hemorrhoid, pilodidal cyst, deciditus ulcers, stasis ulcers, endometriosis, adhesions, salpingo
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)
Nonclinical Performance Data: Data were provided relative to the validation of sterilization parameters required for obtaining 105 SAL utilizing radiation sterilization.
Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Section 5: 510(k) summary
K121471
Date Prepared: 28 June 2012
JUL 1 0 2012
Submitters name, address, telephone, fax, and contact person:
LightScalpel LLC 16932 Woodinville-Redmond Rd NE Suite 201 Woodinville, WA 98072 425-408-9477 425-487-1157 fax Gerald S. Palecki, General Manager
Product Trade Name: LightScalpel family of handpiece tips for CO2 surgical lasers
Product common names: Accessory laser tips
Classification names: Laser surgical instrument for use in general and plastic surgery and in dermatology, 21CFR 878.4810, product code GEX . Panel: General and plastic surgery devices,
Legally marketed predicate device: Aesculight family of fibers, handpieces, and tips for CO2 surgical lasers. (K081612)
Device description: These tips are short, hollow lightpipes of alumina ceramic or stainless steel that provide a variety of spot sizes to target tissue when utilized in a mating laser handpiece.
Intended use: The intended use is to communicate the laser beam of a CO₂ surgical laser to the target site for the incision, excision, ablation, or photocoagulation of soft tissue. Representative examples of indications for use:
Gynecology-excision and vaporization of cervical, vulvar, and perineal condyloma; ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization; vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts.
Dermatology - port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratosis, actinic keratosis and actinic cheilitis.
Dentistry/Oral Surgery - gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors
General Surgery – hemorrhoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of deciditus ulcers and stasis ulcers; mastectomy; breast
1
biopsy, reduction mammoplasty; cyto-reduction for metastatic disease; many dermatological procedures.
Laparoscopic surgery - vaporization, incision, excision, ablation, or photo-coagulation of soft tissue such as endometriosis ablation, excision of adhesions, salpingotomy.
Otorhinolaryngology - lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsillectomy, removal of vocal cord papillomas, nodules, and polyps.
Podiatry - plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neuroma removal; ingrown toenail treatment
Orthopedic - menisectomy, chondromalacia ablation, partial synovectomy, lateral release, PMMA removal
No new indications for use are sought beyond those associated with the predicate device.
Summary technological characteristics and comparison to Predicates: These products are identical to the predicate products, utilizing the same specifications, materials and methods. The only difference between these products and the predicates is the final sterilization method and the attendant packaging and labeling. The sterilization method changes from user steam sterilization with the predicate to pre-sterilized radiation sterilization with the submitted devices. Both sterilization methods demonstrate the ability to sterilize to 10 € SAL.
Nonclinical Performance Data: Data were provided relative to the validation of sterilization parameters required for obtaining 105 SAL utilizing radiation sterilization.
Clinical Performance Data: None
Conclusion: The submitted devices are substantially equivalent to the predicate devices with identical construction and performance with validated sterilization to 100 SAL.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of an eagle.
JUL 10 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
LightScapel, LLC % Mr. Gerald S. Palecki General Manager 16932 Wood-Red Road Northeast Suite 201 Woodinville, Washington 98072
Re: K121471
Trade/Device Name: LightScalpel family of handpiece tips for CO2 surgical lasers 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: May 14, 2012 Received: May 18, 2012
Dear Mr. Palecki:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
3
Page 2 - Mr. Gerald S. Palecki
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.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
signature
2 Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4: Indications for Use Statement
510(k) Number (if known):
Device Name: LightScalpel family of handpiece tips for CO2 surgical lasers
Indications for Use:
Intended use is to communicate the laser beam of a CO2 surgical laser to the target site for the incision, excision, ablation, or photocoagulation of soft tissue. Representative examples of indications for use:
Gynecology-excision and vaporization of cervical, vulvar, and perineal condyloma; ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization; vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts.
Dermatology – port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratosis, actinic keratosis and actinic cheilitis.
Dentistry/Oral Surgery – gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors
General Surgery - hemorrhoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of deciditus ulcers and stasis ulcers; mastectomy; breast biopsy, reduction mammoplasty; cyto-reduction for metastatic disease; many dermatological procedures.
Laparoscopic surgery – vaporization, incision, excision, ablation, or photo-coagulation of soft tissue such as endometriosis ablation, excision of adhesions, salpingotomy.
Otorhinolaryngology - lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsillectomy, removal of vocal cord papillomas, nodules, and polyps.
Podiatry – plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neuroma removal; ingrown toenail treatment
Orthopedic - menisectomy, chondromalacia ablation, partial synovectomy, lateral release, PMMA removal
| Prescription use | Yes |
|---|---|
| (Part 21CFR 801 Subpart D) |
ANDND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Nelkegl Concurrence of CDRH, Office of device Evaluation (ODE)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121471
LightScalpel LLC 510(k) Submission page 4-1