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Portrait PSR

by Rhytec Incorporated

510(k) K082197

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK082197 Date22 Aug 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Rhytec, Inc., Portrait Psr
510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Portrait PSR is a non-ablative fractional laser system (Product Code: GEI) designed to deliver nitrogen-based plasma energy for skin resurfacing and rejuvenation. It targets epidermal and dermal layers to address conditions such as wrinkles, sun damage, and acne scars through controlled tissue remodeling without full-thickness ablation.

This device is intended for use in clinical settings by trained professionals, supplied as a standalone laser machine with ergonomic and portable features. It requires no sterilization as it is not a single-use or reusable consumable but is regulated under FDA 510(k) clearance (K082197) as substantially equivalent to a predicate device, classified under the General, Plastic Surgery advisory committee.

Other devices from Rhytec Incorporated

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of skin conditions is the Portrait PSR laser system specifically designed to treat?

    The Portrait PSR is a non-ablative fractional laser system that targets epidermal and dermal layers to address wrinkles, sun damage, and acne scars. It achieves this through controlled tissue remodeling using nitrogen-based plasma energy, which helps rejuvenate the skin without causing full-thickness ablation.

  • Is the Portrait PSR laser system intended for use in home settings or only in clinical environments?

    The Portrait PSR is designed exclusively for clinical use by trained professionals. Its ergonomic and portable features make it suitable for office-based procedures, but it is not intended for home or self-administration.

  • How is the Portrait PSR laser system regulated by the FDA, and what does that mean for its use?

    The Portrait PSR holds FDA 510(k) clearance (K082197) under the General, Plastic Surgery advisory committee, classified as substantially equivalent to a predicate device. This means it has undergone review to confirm it meets safety and effectiveness standards for its intended clinical use in skin resurfacing and rejuvenation.

  • Does the Portrait PSR require sterilization, and how is it supplied?

    The Portrait PSR is a standalone laser machine and does not require sterilization since it is not a single-use or reusable consumable. It is supplied as a complete device, ready for clinical use by trained professionals without additional disposable components.