(62 days)
Not Found
No
The summary describes a laser system for dermatological treatments and does not mention any AI or ML components.
Yes
The intended uses listed, such as temporary hair reduction, treatment of benign pigmented lesions, treatment of wrinkles, photocoagulation of dermatological vascular lesions, and treatment of scars, directly imply a therapeutic purpose for the device.
No
The document describes the device's indications for treatment purposes (e.g., hair reduction, treatment of lesions, wrinkles) and does not mention any diagnostic functions.
No
The device description clearly states it is a "Laser System" with "two separate laser heads" and a "delivery system," indicating it is a hardware device that produces laser light. The summary also mentions "hardware modifications" and "hardware verification and validation."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The GentleMAX Family of Laser Systems is a laser system that applies light directly to the skin for therapeutic purposes (hair reduction, treatment of lesions, wrinkles). It does not analyze samples taken from the body.
- Intended Use: The intended uses described are all direct treatments applied to the patient's skin.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GentleMAX Family of Laser Systems is indicated for the following:
755nm
The GentleMAX Family of Laser Systems is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias.
1064nm
The GentleMAX Family of Laser Systems is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to. lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
The laser is 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 laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Candela GentleMAX Family of Laser Systems contains two separate laser heads (Alexandrite and Nd: YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen.
The Candela GentleMAX Family of Laser Systems delivers laser energy through an optical fiber handpiece delivery system, which can output either 755 nm or 1064 nm wavelengths. The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch (fingerswitch or footswitch) is used to control the delivery of laser pulses. The Dynamic Cooling Device provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 1.5, 3, 6, 8, 10, 12, 15 and 18 millimeters on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin tissue, dermatological
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)
Minor software and hardware modifications were made to support the changes for the modified GentleMAX Family of Laser Systems (GentleMax Pro Laser System). The testing performed to evaluate these modifications included electromagnetic compatibility (EMC), electrical safety, and software verification and validation. All performance testing demonstrated that the GentleMax Pro Laser System performs according to specifications and functions as intended.
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
Section 7 - 510(k) Summary
510(k) Summary GentleMAX Family of Laser Systems
General Information:
This Special 510(k) is to provide notification of substantial equivalence for the modified GentleMAX Family of Laser Systems (GentleMax Pro Laser System) to the previously cleared GentleMAX Family of Laser Systems manufactured by Candela Corporation.
| Submitted by: | Candela Corporation
530 Boston Post Road
Wayland, MA 01778-1886 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sam Wade,
Global Vice President, Regulatory Affairs
Tel: 508-358-7400 x330
Fax: 508-358-5602 |
| Date prepared: | October 23, 2013 |
| Trade Name: | GentleMAX Family of Laser Systems |
| Common Name: | Dermatology Laser System |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery an
in dermatology (21 CFR 878.4810, Product Code GEX) |
| Predicate Devices: | GentleMAX Family of Laser Systems (K112715) |
Intended Use / Indications for Use:
The GentleMAX Family of Laser Systems is indicated for the following:
755nm
The GentleMAX Family of Laser Systems is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias.
GentleMAX Family of Laser Systems
7-1
1
Section 7 - 510(k) Summary
1064nm
The GentleMAX Family of Laser Systems is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to. lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
The laser is 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 laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
Description:
The Candela GentleMAX Family of Laser Systems contains two separate laser heads (Alexandrite and Nd: YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen.
Technological Characteristics:
The Candela GentleMAX Family of Laser Systems delivers laser energy through an optical fiber handpiece delivery system, which can output either 755 nm or 1064 nm wavelengths. The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch (fingerswitch or footswitch) is used to control the delivery of laser pulses. The Dynamic Cooling Device provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 1.5, 3, 6, 8, 10, 12, 15 and 18 millimeters on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece.
2
Section 7 – 510(k) Summary
| Product | Modified GentleMAX Family of
Laser Systems (GentleMax Pro
Laser System) | GentleMAX Family of Laser
Systems | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) | KXXXXXXX | K112715 | |
| Manufacturer | Candela Corporation | Candela Corporation | |
| Product Code | GEX | GEX | |
| Regulation
Number. | 21 CFR 878.4810 | 21 CFR 878.4810 | |
| Device Class | II | II | |
| Indications for
Use | 755nm | 755nm | |
| | The GentleMAX Family of Laser
Systems is indicated for temporary
hair reduction. Stable long-term or
permanent reduction through
selective targeting of melanin in
hair follicles. Permanent hair
reduction is defined as long-term
stable reduction in the number of
hairs regrowing after a treatment
regime. On all skin types
(Fitzpatrick I- VI) including tanned
skin. Permanent hair reduction is
defined as the long-term, stable
reduction in the number of hairs
regrowing when measured at 6, 9,
and 12 months after the completion
of a treatment regime.
Treatment of benign pigmented
lesions.
Treatment of wrinkles.
The photocoagulation of
dermatological vascular lesions
(such as port-wine stains,
hemangiomas, telangiectasias.
1064nm
The GentleMAX Family of Laser
Systems is indicated for the
removal of unwanted hair, for
stable long term or permanent hair
reduction and for treatment of PFB.
Permanent hair reduction is defined
as the long-term, stable reduction in
the number of hairs regrowing
when measured at 6 9 and 12 | The GentleMAX Family of Laser
Systems is indicated for temporary
hair reduction. Stable long-term or
permanent reduction through
selective targeting of melanin in
hair follicles. Permanent hair
reduction is defined as long-term
stable reduction in the number of
hairs regrowing after a treatment
regime. On all skin types
(Fitzpatrick I- VI) including tanned
skin. Permanent hair reduction is
defined as the long-term, stable
reduction in the number of hairs
regrowing when measured at 6, 9,
and 12 months after the completion
of a treatment regime.
Treatment of benign pigmented
lesions.
Treatment of wrinkles.
The photocoagulation of
dermatological vascular lesions
(such as port-wine stains,
hemangiomas, telangiectasias.
1064nm
The GentleMAX Family of Laser
Systems is indicated for the
removal of unwanted hair, for
stable long term or permanent hair
reduction and for treatment of PFB.
Permanent hair reduction is defined
as the long-term, stable reduction in
the number of hairs regrowing
whan measured at 6 9 and 12 | |
| months after the completion of a
treatment regime. The lasers are
indicated on all skin types
Fitzpatrick I-VI including tanned
skin. Photocoagulation and
hemostasis of pigmented and
vascular lesions such as but not
limited to port wine stains,
hemangioma, warts, telangiectasia,
rosacea, venus lake, leg veins and
spider veins. Coagulation and
hemostasis of soft tissue. Benign
pigmented lesions such as, but not
limited to, lentigos (age spots),
solar lentigos (sun spots), café au
lait macules, seborrheic keratosis,
nevi, chloasma, verrucae, skin tags,
keratosis, tattoos (significant
reduction in the intensity of black
and/or blue-black tattoos) and
plaques.
The laser is 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 laser is also indicated for the
reduction of red pigmentation in
hypertrophic and keloid scars
where vascularity is an integral part
of the scar.
Treatment of wrinkles. | | months after the completion of a
treatment regime. The lasers are
indicated on all skin types
Fitzpatrick I-VI including tanned
skin. Photocoagulation and
hemostasis of pigmented and
vascular lesions such as but not
limited to port wine stains,
hemangioma, warts, telangiectasia,
rosacea, venus lake, leg veins and
spider veins. Coagulation and
hemostasis of soft tissue. Benign
pigmented lesions such as, but not
limited to, lentigos (age spots),
solar lentigos (sun spots), café au
lait macules, seborrheic keratosis,
nevi, chloasma, verrucae, skin tags,
keratosis, tattoos (significant
reduction in the intensity of black
and/or blue-black tattoos) and
plaques.
The laser is 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 laser is also indicated for the
reduction of red pigmentation in
hypertrophic and keloid scars
where vascularity is an integral part
of the scar.
Treatment of wrinkles. | |
| Laser type | Flashlamp-excited, Solid state
Alexandrite and Nd:YAG laser | Flashlamp-excited, Solid state
Alexandrite and Nd:YAG laser | |
| Wavelength | 755nm/1064nm | 755nm/1064nm | |
| Pulse duration | 0.25 - 100 ms | 0.25 - 300 ms | |
| Maximum
fluence | 53 J/cm² (ALEX)
80 J/cm² (YAG) | 53 J/cm² (ALEX)
80 J/cm² (YAG) | |
| Spot size | 1.5, 3, 6, 8, 10, 12, 15, 18mm | 1.5, 3, 6, 8, 10, 12, 15, 18mm | |
| Pulse repetition
rate | 10 Hz, maximum | 10 Hz, maximum | |
| Pulsing control | Fingerswitch or footswitch | Fingerswitch or footswitch | |
| Product
dimensions | 42" x 18" x 27" | 45" x 26.5" x 38" | |
| (HxWxL) | | | |
| Product
Weight | 260 lbs | 341 lbs | |
GentleMAX Family of Laser Systems
7-3
3
4
Section 7 - 510(k) Summary
Performance Data:
Minor software and hardware modifications were made to support the changes for the modified GentleMAX Family of Laser Systems (GentleMax Pro Laser System). The testing performed to evaluate these modifications included electromagnetic compatibility (EMC), electrical safety, and software verification and validation. All performance testing demonstrated that the GentleMax Pro Laser System performs according to specifications and functions as intended.
Clinical Data:
No clinical data was required for these modifications.
Summary of Substantial Equivalence:
The modifications made to the GentleMAX Family of Laser Systems do not affect the indications for use or alter the fundamental scientific technology of the device, nor does it affect the mode of use. There are no labeling changes that affect the indications for use of the device. The modifications made to the GentleMAX Family of Laser Systems raises no new issues of safety or effectiveness. The modified GentleMAX Family of Laser Systems have the samc intended uses, utilizes similar operating principles, and matches key design aspects, including similar spot size, the same wavelength and the same maximum delivered fluence as the predicate devices. The non-clinical tests that were performed that our device is as safe, as effective, and performs as well as the predicate device. On the basis of similarities in methods of assembly, method of operation, and intended uses, as confirmed by the performance testing, Candela Corporation believes that the modified GentleMAX Family of Laser Systems is substantially equivalent to the predicate device.
GentleMAX Family of Laser Systems
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Cemer - WO66-G609 Silver Spring, MD 20993-0002
December 26, 2013
Candela Corporation Mr. Sam Wade Global Vice President, Regulatory Affairs 530 Boston Post Road Wayland, Massachusetts 01778
Re: K133283
Trade/Device Name: Gentlemax Family of Laser Systems 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: December 6, 2013 Received: December 9, 2013
Dear Mr. Wade:
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 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
6
Page 2 - Mr. Sam Wade
ﻪ ﻣﺮﺩﺍﺩ ﺍ
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Section 6 - Indications for Use Statement
Indications for Use Statement
510(k) Number (if known):
GentleMAX Family of Laser Systems Device Name:
Indications for Use:
755mm
.. - ---
The GentleMAX Family of Laser Systems is indicated for temporary hair reduction. Stable longterm or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias)
1064nm
The GentleMAX Family of Laser Systems is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
The laser is 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 laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
GentleMAX Family of Laser Systems
| Jitendra V. Virani -S | |
|---|---|
| 2013.12.26 11:08:06 -05'00' | 6-1 |
| Division Sign-Off | |
| Division of Surgical Devices | A2 - 1 |
| 510(k) Number K133283 |