(90 days)
The family of Altus Medical CoolGlide Aesthetic Lasers are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
1064nm:
Dermatology:
The Altus Medical Aesthetic CoolGlide laser systems are intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The CoolGlide lasers are also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The CoolGlide lasers are also indicated for the removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB).
The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The intended use of the integral cooling system in the Altus CoolGlide laser handpiece is to provide cooling of the skin, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
Surgical Applications:
The lasers are indicated for the incision/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laproscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
Indications for use (532nm):
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)}; benign pigmented lesions (nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses: plaques: cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
Family of Altus Medical CoolGlide Aesthetic Lasers are comprised of the following main components:
- a laser system console (including software and control electronics);
- a control and display panel;
- a permanently attached fiberoptic-coupled handpiece;
- a skin cooling device integrated into the handpiece;
- a footswitch (or finger-operated exposure switch (handswitch) option integrated into the handpiece)
- a remote interlock connector (disables laser when treatment room door is opened).
This document is a 510(k) Summary for the Altus Medical CoolGlide Aesthetic Lasers, which focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed performance data against specific acceptance criteria from a clinical study.
Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be found in the provided text.
The document primarily states that the safety and effectiveness are based on the technological identity and similar indications for use to predicate devices. It does not describe a new clinical study to establish performance against acceptance criteria for this specific submission.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or quantitative performance metrics are provided in the document. The basis for clearance is "substantial equivalence" to predicate devices, implying that their established performance applies.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not specified directly in this document | Not specified directly in this document, as performance is inferred from predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a new test set or clinical study for this 510(k) submission. Acceptance is based on comparison to predicate devices already on the market.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. No new test set requiring expert-established ground truth is described.
4. Adjudication Method for the Test Set
Not applicable. No new test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improvement with AI vs without AI assistance
Not applicable. This is a laser device, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a laser device, not an algorithm, and no standalone performance study is mentioned.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating safety and effectiveness implicitly refers to the established safety and efficacy profiles of the predicate devices cleared by the FDA. There is no new ground truth established for this submission.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, and the document describes its substantial equivalence to existing devices, not the training of an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a medical device, and the document describes its substantial equivalence to existing devices, not the training of an algorithm.
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OCT 0 8 2002
KO22226 Attachment 17 510(k) Summary for the Family of Altus Medical CoolGlide Aesthetic Lasers
【. General Information
| Submitter: | Altus Medical, Inc.821 Cowan RoadBurlingame, CA 94010 |
|---|---|
| Contact Persons: | Kathy MaynorMike Levernier |
| Summary Preparation Date: July 5, 2002 |
II. Names
| Device Names: | Family of Altus Medical CoolGlide Aesthetic Lasers |
|---|---|
| Primary Classification Name: | Laser Powered Surgical Instrument (and Accessories |
III. Predicate Devices
- Family of CoolGlide Aesthetic Lasers, manufactured by Altus Medical (K991798, ● K991234, K003202 and K014040);
- NLite Pulsed Dye Laser, manufactured by ICN (K000811, K014130, and K013461); .
- . Vbeam and Clearbeam Pulsed Dye Lasers, manufactured by Candela (K013043 and K013748);
- . PhotoGenica Pulsed Dye Laser, manufactured by Cynosure (K012806);
- CoolTouch I and CoolTouch II Nd:YAG lasers, manufactured by ICN (K014035 and . K003715); and
- . Smoothbeam Diode Laser, manufactured by Candela (K013825).
- . Lyra Surgical Laser System, manufactured by Laserscope (K020021)
IV. Product Description
Family of Altus Medical CoolGlide Aesthetic Lasers are comprised of the following main components:
- · a laser system console (including software and control electronics);
- · a control and display panel;
- · a permanently attached fiberoptic-coupled handpiece;
- · a skin cooling device integrated into the handpiece;
- · a footswitch (or finger-operated exposure switch (handswitch) option integrated into the handpiece)
- · a remote interlock connector (disables laser when treatment room door is opened).
{1}------------------------------------------------
V. Indications for Use
The family of Altus Medical CoolGlide Aesthetic Lasers are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
1064nm:
Dermatology:
The Altus Medical Aesthetic CoolGlide laser systems are intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The CoolGlide lasers are also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The CoolGlide lasers are also indicated for the removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB).
The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The intended use of the integral cooling system in the Altus CoolGlide laser handpiece is to provide cooling of the skin, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
{2}------------------------------------------------
Surgical Applications:
The lasers are indicated for the incision/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laproscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
Indications for use (532nm):
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)}; benign pigmented lesions (nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses: plaques: cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
VI. Rationale for Substantial Equivalence
The family of Altus Medical CoolGlide Aesthetic Lasers share the same general indications for use, and therefore is substantially equivalent to the currently marketed Altus Medical family of CoolGlide Aesthetic Nd:YAG Lasers (K991798, K991234, K003202 and K014040), the NLite Pulsed Dye Laser, manufactured by ICN (K000811, K014130, and K013461), the Vbeam and Clearbeam Pulsed Dye Lasers, manufactured Candela (K013043 and K013748), the PhotoGenica Pulsed Dye Laser, manufactured by Cynosure (K012806), the CoolTouch I and CoolTouch II Nd: YAG lasers, manufactured by ICN (K014035 and K003715), the Smoothbeam Diode Laser, manufactured by Candela (K013825), and the Lyra Surgical Laser System, manufactured by Laserscope (K020021).
VII. Safety and Effectiveness Information
The new indications for use in dermatology, endoscopic/laproscopic general surgery, gastroenterology, general surgery, gynecology, otorhinolaryngology, neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary.thoracic surgery, and urology are based upon the indications for use for predicate laser systems.
Technologically, the CoolGlide family of aesthetic lasers is identical to the previous predicate CoolGlide family (K014040). Therefore the risks and benefits for the CoolGlide laser family are comparable to the predicate devices.
We therefore believe that there are no questions of safety or effectiveness raised by the introduction of this device.
{3}------------------------------------------------
VIII. Conclusion
The family of Altus Medical CoolGlide Aesthetic Lasers were found to be substantially equivalent to the currently marketed Altus Medical family of CoolGlide Aesthetic Nd:YAG Lasers (K991798, K991234, K003202 and K014040), the NLite Pulsed Dye Laser, manufactured by ICN (K000811, K014130, and K013461), the Vbeam and Clearbeam Pulsed Dye Lasers, manufactured Candela (K013043 and K013748), the PhotoGenica Pulsed Dye Laser, manufactured by Cynosure (K012806), the CoolTouch I and CoolTouch II Nd:YAG lasers, manufactured by ICN (K014035 and K003715), the Smoothbeam Diode Laser, manufactured by Candela (K013825), and the Lyra Surgical Laser System, manufactured by Laserscope (K020021). The family of Altus Medical CoolGlide Aesthetic Lasers share similar indications for use, design features, and similar functional features as, and thus are substantially equivalent to, the currently marketed predicate devices.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and humanity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 8 2002
Altus Medical, Inc. Michael Levernier Vice President, Clinical Development 821 Cowan Road Burlingame, California 94010
Re: K022226
Trade/Device Name: Family of Altus Medical CoolGlide Aesthetic Lasers Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: July 5, 2002 Received: July 10, 2002
Dear Mr. Levernier:
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.
{5}------------------------------------------------
Page 2 – Mr. Michael Levernier
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 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 vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Styph Rurle
A 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
{6}------------------------------------------------
Attachment 2 Indications For Use Statement as Requested by FDA
510(k) Number (if Known): _
510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________
Device Name: Family of Altus Medical CoolGlide Aesthetic Lasers
Indications For Use:
The family of Altus Medical CoolGlide Aesthetic Lasers are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
1064nm:
Dermatology:
The Altus Medical Aesthetic CoolGlide laser systems are intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office, of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative and Neurological Devices |
| 510(k) Number | K022226 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)510(k) Submission: Family of Altus Medical Modified CoolGlide Aesthetic Lasers
{7}------------------------------------------------
The CoolGlide lasers are also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The CoolGlide lasers are also indicated for the removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB).
The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The intended use of the integral cooling system in the Altus CoolGlide laser handpiece is to provide cooling of the skin, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
Surgical Applications:
lasers are indicated for the incision/excision and cutting, ablation, The coagulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laproscopy, gastroenterology, general surgery, surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styt Rurda
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_KO22226
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
{8}------------------------------------------------
532mm:
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stypt. Diode
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_KOZ222226
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use -------
(Optional Format 1-2-96)
§ 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.