Fraxel SR Laser System
by Reliant Technologies, Inc. 2 variants
510(k) K050841
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK050841 | Date5 Jul 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Fraxel SR Laser System is a fractional laser device designed for fractional photothermolysis, a technique used to resurface and rejuvenate skin. It employs a 1550nm wavelength to deliver precise, controlled energy to the skin, targeting soft tissue coagulation and improving skin texture, tone, and radiance. The system is intended for dermatological procedures, including the treatment of dyschromia and cutaneous lesions such as lentigos, solar lentigos, actinic keratosis, and melasma. Its fractional approach minimizes downtime and side effects compared to traditional ablative resurfacing methods.
The Fraxel SR Laser System is supplied as a reusable medical device and is intended for use in clinical settings by trained professionals. It requires proper training and adherence to manufacturer guidelines for safe operation. The system is not sterile at the point of sale but is designed for use in controlled environments where sterilization protocols can be followed. No specific regulatory status beyond FDA 510(k) clearance under K050841 is stated in the provided data.
Other devices from Reliant Technologies, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Fraxel SR Laser System used for?
The Fraxel SR Laser System is designed for fractional photothermolysis, a technique that targets soft tissue coagulation to improve skin texture, tone, and radiance. It is specifically indicated for dermatological procedures such as treating dyschromia and cutaneous lesions, including lentigos, solar lentigos, actinic keratosis, and melasma. The fractional approach reduces downtime and side effects compared to traditional ablative resurfacing methods.
How is the Fraxel SR Laser System supplied and prepared for use?
The Fraxel SR Laser System is supplied as a reusable medical device and is not sterile at the point of sale. It is intended for use in clinical settings where proper sterilization protocols can be followed. Safe operation requires adherence to manufacturer guidelines and appropriate training for healthcare professionals.
Is the Fraxel SR Laser System single-use or reusable?
The Fraxel SR Laser System is a reusable device, designed for repeated use in controlled clinical environments. Reusability is contingent on following manufacturer-recommended sterilization procedures to ensure safety and efficacy between patient treatments.
What wavelength does the Fraxel SR Laser System use, and why is it significant?
The Fraxel SR Laser System employs a 1550nm wavelength, which is optimized for fractional photothermolysis. This wavelength allows for precise energy delivery to the skin, targeting deeper tissue layers while minimizing damage to the epidermis. This results in improved skin rejuvenation with reduced risk of scarring or prolonged downtime compared to ablative methods.
What regulatory clearance does the Fraxel SR Laser System hold?
The Fraxel SR Laser System holds FDA 510(k) clearance under the reference number K050841. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device and meets regulatory standards for safety and effectiveness in its intended use.