Isolaz 2 Intense Pulsed Light System
510(k) K121515
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121515 | Date5 Jun 2012 | 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- Withdrawn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
- ONF
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Isolaz 2 Intense Pulsed Light System is a powered light-based non-laser surgical instrument with thermal effect, designed to deliver non-coherent light therapy. It is classified as a Class II device under FDA regulations and is intended for use in dermatological treatments, specifically targeting mild to moderate acne conditions such as pustular, comedonal, and inflammatory acne (acne vulgaris).
This system comprises a main console and a treatment handpiece, which delivers light via a photopneumatic mechanism. It is supplied as a reusable device and is regulated under FDA 510(k) clearance (K121515) with a special classification for substantial equivalence. The device operates under the regulatory framework outlined in 878.4810 and is intended for use in clinical settings by trained operators.
Other devices from Solta Medical, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of acne conditions is the Isolaz 2 Intense Pulsed Light System specifically designed to treat?
The Isolaz 2 is designed for dermatological treatments targeting mild to moderate acne conditions, including pustular, comedonal, and inflammatory acne (acne vulgaris). It uses non-coherent light therapy via a photopneumatic mechanism to address these specific skin concerns.
How is the Isolaz 2 system supplied, and is it reusable?
The Isolaz 2 system is supplied as a reusable device, consisting of a main console and a treatment handpiece. This means it is intended for repeated use in clinical settings after proper cleaning and maintenance, rather than being single-use.
What regulatory pathway was followed for FDA clearance of the Isolaz 2, and what does this mean for its use?
The Isolaz 2 received FDA clearance through a 510(k) pathway, specifically classified as a Class II device with a special classification for substantial equivalence. This means it was determined to be substantially equivalent to a legally marketed device and is regulated under FDA guidelines for powered light-based non-laser surgical instruments with thermal effects, intended for dermatological use.
What medical specialties are primarily involved in using the Isolaz 2 system?
The Isolaz 2 system is primarily intended for use in clinical settings by trained operators within the fields of General and Plastic Surgery, as indicated by its regulatory submission and advisory committee classification.
Does the Isolaz 2 system require any special handling or storage conditions?
While the provided data does not specify exact storage conditions, as a reusable medical device, the Isolaz 2 system should be stored in a clean, dry environment according to manufacturer guidelines to ensure proper functionality and hygiene. Always follow Solta Medical’s instructions for cleaning, maintenance, and sterilization protocols.