Chrome

Quanta System Spa

Country / region:Italy (IT)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

6

Device details

FDA 510(k) registration fields

K number
K202503
Device name
Chrome
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2020-08-31
Decision date
2020-11-18
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Vascular treatmentPigment treatmentSurgical cutting
Primary application
Vascular treatment
Classification source
AI classified

Indications for Use

Chrome is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

Indications for use:

1064 & 532 nm (Q-Switched, nanosecond mode)
Chrome is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:

532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
- Treatment of benign vascular lesions including, but not limited to:
  - port wine birthmarks
  - telangiectasias
  - spider angioma
  - Cherry angioma
  - Spider nevi
- Treatment of benign pigmented lesions including, but not limited to:
  - cafe-au-lait birthmarks
  - Ephalides, solar lentigines
  - senile lentigines
  - Becker's nevi
  - freckles
  - common nevi
  - nevus spilus
  - Ota Nevus
- Treatment of seborrheic keratosis
- Treatment of post inflammatory hyperpigmentation
- Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- Removal of dark ink (black, blue and brown) tattoos
- Removal of benign pigmented lesions including;
  - nevus of Ota
  - Café au lait spot
  - Ephalides, solar lentigo (lentigines)
  - Becker Nevus
  - Nevus spilus
- Treatment of common nevi
- Removal or lightening of unwanted hair
- Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064 nm (pulsed)
Dermatology/Plastic Surgery:
- Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, 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 laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.
- The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
- The laser is also indicated for the treatment of facial wrinkles.
- Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as 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.
- It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- The l

Intended Use

Chrome is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery. Indications include treatment of benign vascular lesions, benign pigmented lesions, hair and tattoo removal, and skin resurfacing procedures for acne scars and wrinkles.

Device Description

Chrome is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at 532 nm and 1064 nm (Nd:YAG laser). Chrome can be equipped with intense pulsed light handpieces (Twain IPL) emitting at wavelengths from 400-1200 nm. It can also connect to Er:YAG handpieces. The optical delivery system is an articulated arm with fixed or variable handpieces, and the device is controlled via a touch screen display.

Summary parsed at:2026-06-01 05:48:37 UTC

Predicate devices

3

K202503 references 3 predicate/reference devices

Cited as predicate

6

6 submissions cite K202503 as a predicate