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Pulsed light (IPL)

BBL (BroadBand Light) by Sciton

Sciton, Inc.

FDA-cleared device (510(k)) — cleared, not approvedChecked Sep 14, 2026 · Partly confirmed

What it is

Maker
Sciton, Inc.
Category
Pulsed light (IPL)
Also called
BBL, BroadBand Light, Sciton BBL, BBL HERO, Profile BBL, photofacial

FDA status

Pathway
FDA-cleared device (510(k)) — cleared, not approved
First approved or cleared
2003

Research notes

BBL indications are recorded from the BBL (300-1400 nm) section of the JOULE Multi-Platform System 510(k), K101916, cleared 2011-03-18; the extracted text was cut off after the vascular-lesion item, so the list may be incomplete. The earliest BBL-named clearance opened is PROFILE BBL SYSTEM, K032460, cleared 2003-11-13. No separate 510(k) naming the current 'BBL HERO' model was found in Sciton's openFDA records; which clearance covers the current BBL hardware was not confirmed. FDA regulates BBL as a powered laser surgical instrument class (21 CFR 878.4810, product code GEX).

What it’s authorized for

As recorded from the FDA record and labeling cited below.

  • Light-based treatment (selective photothermolysis) for surgical, aesthetic and cosmetic uses in dermatology and plastic surgery, including:
  • Mild to moderate inflammatory and pustular acne
  • Benign pigmented lesions, including uneven pigmentation, hyperpigmentation, melasma and freckles
  • Cutaneous lesions including warts, scars and stretch marks (striae)
  • Benign vascular lesions, including port wine stains, hemangiomas, and facial, trunk and leg telangiectasias (spider veins)

How it’s sold

How it’s sold isn’t recorded for this entry.

What the label warns about

No label warning is recorded here. That isn’t the same as the label having none — the research notes and sources say what was opened.

Checking it’s the real thing

No FDA authenticity notice is recorded for this product.

Ask in the room

“What’s the brand name printed on the box, vial or device panel — and may I see it?”

Recalls and enforcement

FDA recall and enforcement records filed under K101916, read live from openFDA. A recall usually covers particular models or lots, not every unit ever made.

Searching FDA recall and enforcement records by this product’s FDA number…

Look up K101916 and a number from the box

Check it yourself

Device proof ladder: The room sells a laser, RF, microneedling, body-contouring, light, or other hardware result. Work down in order — each step needs the one before it.

  1. Read the panelGet the exact manufacturer and model from the device itself.
  2. Find the authorizationSearch 510(k) and De Novo by model/manufacturer, not treatment nickname.510(k) Premarket Notification database (opens in a new tab) · U.S. Food & Drug Administration
  3. Match identityUse AccessGUDID when a UDI or device identifier is available.AccessGUDID (opens in a new tab) · FDA / National Library of Medicine
  4. Read maker instructionsCompare the proposed use with current manufacturer labeling/IFU for that exact model.
  5. Check post-market recordSearch recalls/corrections after the model is known.Medical Device Recalls (opens in a new tab) · U.S. Food & Drug Administration
  6. Verify the operatorThen check the person's applicable state credential and device-specific training.

Worth knowing

What an FDA record can and can’t tell you

FDA records show what was authorized, for what, and when.

They can’t show that the product in the room is authentic, in date, stored properly, or being used for its authorized purpose. Those are questions for the room.

Sources

  1. FDA 510(k) database: K101916 (JOULE MULTI-PLATFORM SYSTEM) (opens in a new tab)FDA database
  2. FDA 510(k) summary and Indications for Use, K101916 (includes BBL module) (opens in a new tab)FDA database
  3. FDA 510(k) database: K032460 (PROFILE BBL SYSTEM) (opens in a new tab)FDA database

Checked Sep 14, 2026 · Partly confirmed.

Treatments that use it

Product identity

Told a name? Shown a box?

Type what was said or printed, see whether it matches a registry entry, and note what you saw in your booking file.

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