EpiLight Hair Removal System, Photoderm HR System
by Esc Medical Systems, Ltd. 510(k)
Active
510(k) K991935
Overview
The EpiLight Hair Removal System, Photoderm HR System is a powered laser surgical instrument designed for photothermal hair removal. It employs light energy to selectively target and thermally destroy hair follicles while preserving surrounding tissue, achieving long-term hair reduction in skin types I–V. This device operates on the principle of selective photothermolysis, where melanin in hair follicles absorbs light energy to generate controlled thermal damage. The system is classified under the GEX product code for powered laser surgical instruments.
This device is supplied as a medical-grade system intended for use in clinical settings by trained professionals. It is not described as single-use or reusable in the regulatory data, though its intended use requires adherence to standard laser safety and sterilisation protocols. The system is authorised under an FDA 510(k) clearance (K991935) and falls under the General, Plastic Surgery advisory committee classification. No additional regulatory markings or sterility guarantees are specified beyond its classification as a powered laser surgical instrument.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991935 | Date27 Jan 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEX
- FDA applicant
- Esc Medical Systems , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Esc Medical Systems, Inc.
Questions
What is the EpiLight Photoderm HR System used for?
The EpiLight Photoderm HR System is a powered laser surgical instrument designed specifically for photothermal hair removal. It uses light energy to target and destroy hair follicles through selective photothermolysis, where melanin in the follicles absorbs light to create controlled thermal damage. This process helps achieve long-term hair reduction while preserving surrounding skin tissue. It is intended for use on skin types I–V and is approved for clinical settings by trained professionals.
Is the EpiLight Photoderm HR System single-use or reusable?
The regulatory data does not explicitly classify the EpiLight Photoderm HR System as single-use or reusable. However, as a medical-grade laser instrument intended for clinical use, it must adhere to standard laser safety and sterilization protocols. Proper maintenance, cleaning, and sterilization procedures are essential to ensure safe and effective operation, particularly in a multi-patient environment.
What safety and regulatory standards apply to this device?
The EpiLight Photoderm HR System holds an FDA 510(k) clearance (K991935), indicating it is deemed substantially equivalent to a legally marketed device. It falls under the GEX product code for powered laser surgical instruments and was reviewed by the General, Plastic Surgery advisory committee. While no additional regulatory markings or sterility guarantees are specified beyond its classification, its use requires compliance with standard laser safety protocols to ensure patient and operator protection.
How is the EpiLight Photoderm HR System supplied?
The EpiLight Photoderm HR System is supplied as a complete medical-grade laser hair removal system intended for use in clinical environments. It is not described as a disposable or single-use item, so it is designed for professional use with appropriate maintenance and sterilization procedures. The system is meant to be operated by trained professionals in controlled settings to ensure safe and effective hair removal treatments.
What skin types is the Photoderm HR System approved for?
The EpiLight Photoderm HR System is approved for use on skin types I–V. This range accounts for varying melanin levels in different skin tones, allowing the device to selectively target hair follicles while minimizing damage to surrounding tissue. The system’s design ensures it can be safely and effectively applied across these diverse skin types for long-term hair reduction.