Who is the manufacturer of CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS?

Candela Corp. filed the 510(k) submission for CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS (K133283).

What is the FDA product code for CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS

Q: What are the predicate devices for CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS?

GentleMAX Family of Laser Systems (K112715).

K133283 · Candela Corp. · GEX · Dec 26, 2013 · General, Plastic Surgery

Device Facts

Record ID	K133283
Device Name	CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
Applicant	Candela Corp.
Product Code	GEX · General, Plastic Surgery
Decision Date	Dec 26, 2013
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Dermatology laser system; dual-head (Alexandrite 755nm and Nd:YAG 1064nm); optical fiber delivery; fingerswitch/footswitch controlled. Inputs: user-selected laser parameters. Operation: high-intensity light penetrates skin; therapeutic heat delivery; Dynamic Cooling Device (DCD) provides cryogen spray burst for epidermal protection. Output: laser pulses for hair reduction, vascular/pigmented lesion treatment, and soft tissue coagulation. Used in clinical settings by trained professionals. Output allows clinicians to perform dermatological procedures; benefits include hair reduction and lesion clearance.

Clinical Evidence

No clinical data required for these modifications. Substantial equivalence supported by non-clinical performance testing including electromagnetic compatibility, electrical safety, and software verification and validation.

Technological Characteristics

Flashlamp-excited, solid-state Alexandrite (755nm) and Nd:YAG (1064nm) laser. Optical fiber delivery system with replaceable handpieces. Spot sizes: 1.5-18mm. Pulse duration: 0.25-100ms. Max fluence: 53 J/cm² (Alex), 80 J/cm² (YAG). Dynamic Cooling Device (DCD) uses cryogen spray. Standalone system.

Indications for Use

Indicated for hair reduction (temporary/permanent), treatment of benign pigmented lesions, wrinkles, and dermatological vascular lesions (e.g., port-wine stains, hemangiomas, telangiectasias, PFB, rosacea, leg/spider veins). Applicable to all skin types (Fitzpatrick I-VI) including tanned skin. Also indicated for soft tissue coagulation/hemostasis and reduction of red pigmentation in hypertrophic/keloid scars.

Regulatory Classification

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.

Predicate Devices

GentleMAX Family of Laser Systems (K112715)

Related Devices

K201111 — GentleMax Pro Plus · Candela Corporation · May 26, 2020
K181486 — DEKA Motus AY · El.En Electronic Engineering Spa · Aug 30, 2018
K182663 — Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System · Finemec Co., Ltd. · Nov 30, 2018
K112715 — CANDELA GENTLEMAX FAMILY OF LASERS · Candela Corp. · Oct 5, 2011
K243630 — Medical Laser System Incanto / Evoline Platinum /Evoline · Solar LS Cjsc · Mar 21, 2025

Submission Summary (Full Text)

{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.…